4,448 Professional Standards jobs in the United States
Director Quality Assurance Regulatory Affairs
92002 Carlsbad, California
BioTalent
Posted today
Job Viewed
Job Description
Director of Quality & Regulatory Affairs – Medical Devices
Location: North San Diego | Full-time | Medical Device Industry
We are seeking a Director of Quality & Regulatory Affairs to provide strategic leadership and oversight of compliance, regulatory, and quality activities for our breakthrough medical technologies. This is a high-impact role responsible for ensuring patient safety, regulatory success, and operational excellence as we bring innovative devices to market.
Compliance & Risk Management
- Act as Management Representative of the Quality Management System (QMS), ensuring compliance with ISO 13485, FDA Quality System Regulation (QSR) , and global standards for sterile implantable and electronic devices.
- Lead Risk Management activities per ISO 14971 , guiding the Risk Management Team in assessing product changes and monitoring design/development activities for compliance with design controls.
- Manage internal audits , post-market surveillance, regulatory notifications, and customer communications related to complaints and investigations.
Regulatory Affairs
- Define regulatory pathways for new products and product changes (e.g., Letter to File, 510(k) submissions).
- Coordinate with regulatory consulting partners to prepare and execute 510(k) submissions for Class II devices .
- Maintain oversight of labeling, documentation, and regulatory assessments throughout the product lifecycle.
Design Verification & Validation (V&V)
- Review design documentation & support development of V&V protocols to confirm conformance to specifications, standards, and process controls using statistically valid methods.
- Oversee data collection and reporting for V&V results, software validation, hardware testing, and performance testing protocols.
Quality Assurance & Operations
- Oversee management of Nonconforming Materials (NCMR) , Corrective and Preventive Actions (CAPA), and supplier qualification metrics.
- Guide creation and implementation of inspection and test methods , improving manufacturing quality, product assembly, and inspection integrity.
- Contribute to building and maintaining the Design History File (DHF) and Device Master Record (DMR) .
- Lead document control and change order management across the organization.
Qualifications
- Bachelor’s degree in engineering, life sciences, or related field (advanced degree preferred).
- 10+ years in the medical device industry , with at least 5 years in a leadership role.
- Deep knowledge of FDA/QSR, ISO 13485, ISO 14971 and related international standards.
- Experience leading 510(k) preparation and submissions for Class II devices.
- Technical proficiency in MS Office, Matlab, PLM systems (Agile) , and application of statistical techniques.
- Strong interpersonal, leadership, and communication skills to influence across departments and drive compliance.
View Now
0
Director Quality Assurance Regulatory Affairs
Carlsbad, California
BioTalent
Posted today
Job Viewed
Job Description
Director of Quality & Regulatory Affairs – Medical Devices
Location: North San Diego | Full-time | Medical Device Industry
We are seeking a Director of Quality & Regulatory Affairs to provide strategic leadership and oversight of compliance, regulatory, and quality activities for our breakthrough medical technologies. This is a high-impact role responsible for ensuring patient safety, regulatory success, and operational excellence as we bring innovative devices to market.
Compliance & Risk Management
- Act as Management Representative of the Quality Management System (QMS), ensuring compliance with ISO 13485, FDA Quality System Regulation (QSR), and global standards for sterile implantable and electronic devices.
- Lead Risk Management activities per ISO 14971, guiding the Risk Management Team in assessing product changes and monitoring design/development activities for compliance with design controls.
- Manage internal audits, post-market surveillance, regulatory notifications, and customer communications related to complaints and investigations.
Regulatory Affairs
- Define regulatory pathways for new products and product changes (e.g., Letter to File, 510(k) submissions).
- Coordinate with regulatory consulting partners to prepare and execute 510(k) submissions for Class II devices.
- Maintain oversight of labeling, documentation, and regulatory assessments throughout the product lifecycle.
Design Verification & Validation (V&V)
- Review design documentation & support development of V&V protocols to confirm conformance to specifications, standards, and process controls using statistically valid methods.
- Oversee data collection and reporting for V&V results, software validation, hardware testing, and performance testing protocols.
Quality Assurance & Operations
- Oversee management of Nonconforming Materials (NCMR), Corrective and Preventive Actions (CAPA), and supplier qualification metrics.
- Guide creation and implementation of inspection and test methods, improving manufacturing quality, product assembly, and inspection integrity.
- Contribute to building and maintaining the Design History File (DHF) and Device Master Record (DMR).
- Lead document control and change order management across the organization.
Qualifications
- Bachelor’s degree in engineering, life sciences, or related field (advanced degree preferred).
- 10+ years in the medical device industry, with at least 5 years in a leadership role.
- Deep knowledge of FDA/QSR, ISO 13485, ISO 14971 and related international standards.
- Experience leading 510(k) preparation and submissions for Class II devices.
- Technical proficiency in MS Office, Matlab, PLM systems (Agile), and application of statistical techniques.
- Strong interpersonal, leadership, and communication skills to influence across departments and drive compliance.
View Now
1
Director Quality Assurance Regulatory Affairs (Carlsbad)
92002 Carlsbad, California
BioTalent
Posted 2 days ago
Job Viewed
Job Description
Director of Quality & Regulatory Affairs Medical Devices
Location: North San Diego | Full-time | Medical Device Industry
We are seeking a Director of Quality & Regulatory Affairs to provide strategic leadership and oversight of compliance, regulatory, and quality activities for our breakthrough medical technologies. This is a high-impact role responsible for ensuring patient safety, regulatory success, and operational excellence as we bring innovative devices to market.
Compliance & Risk Management
- Act as Management Representative of the Quality Management System (QMS), ensuring compliance with ISO 13485, FDA Quality System Regulation (QSR) , and global standards for sterile implantable and electronic devices.
- Lead Risk Management activities per ISO 14971 , guiding the Risk Management Team in assessing product changes and monitoring design/development activities for compliance with design controls.
- Manage internal audits , post-market surveillance, regulatory notifications, and customer communications related to complaints and investigations.
Regulatory Affairs
- Define regulatory pathways for new products and product changes (e.g., Letter to File, 510(k) submissions).
- Coordinate with regulatory consulting partners to prepare and execute 510(k) submissions for Class II devices .
- Maintain oversight of labeling, documentation, and regulatory assessments throughout the product lifecycle.
Design Verification & Validation (V&V)
- Review design documentation & support development of V&V protocols to confirm conformance to specifications, standards, and process controls using statistically valid methods.
- Oversee data collection and reporting for V&V results, software validation, hardware testing, and performance testing protocols.
Quality Assurance & Operations
- Oversee management of Nonconforming Materials (NCMR) , Corrective and Preventive Actions (CAPA), and supplier qualification metrics.
- Guide creation and implementation of inspection and test methods , improving manufacturing quality, product assembly, and inspection integrity.
- Contribute to building and maintaining the Design History File (DHF) and Device Master Record (DMR) .
- Lead document control and change order management across the organization.
Qualifications
- Bachelors degree in engineering, life sciences, or related field (advanced degree preferred).
- 10+ years in the medical device industry , with at least 5 years in a leadership role.
- Deep knowledge of FDA/QSR, ISO 13485, ISO 14971 and related international standards.
- Experience leading 510(k) preparation and submissions for Class II devices.
- Technical proficiency in MS Office, Matlab, PLM systems (Agile) , and application of statistical techniques.
- Strong interpersonal, leadership, and communication skills to influence across departments and drive compliance.
View Now
2
Quality Assurance & Regulatory Affairs Compliance Specialis, Investigations
33747 St. Petersburg, Florida
Catalent Pharma Solutions
Posted 2 days ago
Job Viewed
Job Description
**Quality Assurance & Regulatory Affairs Compliance Specialist**
**Position Summary**
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
St. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion capsules per year. The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug candidates. Non-gelatin based OptiShell® and Vegicaps® capsules expand the range of molecules into softgel, ideal for challenging fill formulation. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve your most difficult development and manufacturing challenges.
The **Quality Assurance & Regulatory Affairs Compliance Specialist** is responsible for quality and regulatory affairs services at the site level. The **Quality Assurance & Regulatory Affairs Compliance Specialist** will support the primary coordination of the Change Control processes for the site, also including but not limited to, Drug Master File (DMF) Updates, Health Authority GMP requests, processing and investigating customer product complaints, preparing annual product reviews, and tracking and trending.
Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
The position is 100% on-site at our St. Petersburg, FL location.
**The Role**
+ Coordinate, Track, and Trend Change Controls issued for the facility. Ensuring change controls meet the initial requirements for implementation and reviewing completed change controls to ensure all actions have been appropriately completed.
+ Provide initial regulatory impact assessment on all change controls as required.
+ Liaise with customers to ensure customer requirements are satisfied.
+ Preparation and submission of A/NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual reports); plant/site master files; licenses, permits, and registrations to meet FDA and State requirements (especially Florida); other submissions as required.
+ Prepare and submit all federal, state and local permits in a timely manner.
+ Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure on time closure.
+ Collaborates with Subject Matter Experts (SME)s, management and supervisory personnel from applicable areas to resolve problems affecting product quality; collaboration includes investigating and CAPA initiation, following up on issues and a working jointly towards resolution.
+ Perform other duties as assigned.
**The Candidate**
+ Bachelor's degree in science or related field required (Chemistry, Microbiology or Biology) required.
+ A minimum of 3 years' related experience in the pharmaceutical manufacturing industry required.
+ Prior experience working with investigation writing, including root cause analysis and report writing a must (prior experience with preparing annual product reviews preferred). PathWise Certification preferred.
+ Background working with Change Controls and management of change control processes preferred.
+ Ability to solve problems with little guidance. Ability to identify the most efficient method to achieve predetermined objective. Ability to work effectively under pressure with constantly changing priorities and deadlines. Individuals may be required to sit, stand, walk regularly and occasionally lift to 15 lbs.; no lifting greater than 44.09 pounds without assistance. Specific vision requirements include reading of written documents and use of computer monitor screen frequently. Ability to work extended hours or off-hours as required.
**Why You Should Join Catalent**
+ Tuition Reimbursement - Let us help you finish your degree or earn a new one!
+ WellHub program to promote overall physical wellness.
+ 152 hours of PTO + 8 paid holidays.
+ Medical, dental and vision benefits effective day one of employment.
+ Defined career path and annual performance review and feedback process.
+ Diverse, inclusive culture. Several Employee Resource Groups focusing on D&I. Community engagement and green initiatives.
+ Dynamic, fast-paced work environment.
+ Positive working environment focusing on continually improving processes to remain innovative.
+ Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
+ Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.
**Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers ( to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE ( .
**Position Summary**
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
St. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion capsules per year. The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug candidates. Non-gelatin based OptiShell® and Vegicaps® capsules expand the range of molecules into softgel, ideal for challenging fill formulation. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve your most difficult development and manufacturing challenges.
The **Quality Assurance & Regulatory Affairs Compliance Specialist** is responsible for quality and regulatory affairs services at the site level. The **Quality Assurance & Regulatory Affairs Compliance Specialist** will support the primary coordination of the Change Control processes for the site, also including but not limited to, Drug Master File (DMF) Updates, Health Authority GMP requests, processing and investigating customer product complaints, preparing annual product reviews, and tracking and trending.
Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
The position is 100% on-site at our St. Petersburg, FL location.
**The Role**
+ Coordinate, Track, and Trend Change Controls issued for the facility. Ensuring change controls meet the initial requirements for implementation and reviewing completed change controls to ensure all actions have been appropriately completed.
+ Provide initial regulatory impact assessment on all change controls as required.
+ Liaise with customers to ensure customer requirements are satisfied.
+ Preparation and submission of A/NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual reports); plant/site master files; licenses, permits, and registrations to meet FDA and State requirements (especially Florida); other submissions as required.
+ Prepare and submit all federal, state and local permits in a timely manner.
+ Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure on time closure.
+ Collaborates with Subject Matter Experts (SME)s, management and supervisory personnel from applicable areas to resolve problems affecting product quality; collaboration includes investigating and CAPA initiation, following up on issues and a working jointly towards resolution.
+ Perform other duties as assigned.
**The Candidate**
+ Bachelor's degree in science or related field required (Chemistry, Microbiology or Biology) required.
+ A minimum of 3 years' related experience in the pharmaceutical manufacturing industry required.
+ Prior experience working with investigation writing, including root cause analysis and report writing a must (prior experience with preparing annual product reviews preferred). PathWise Certification preferred.
+ Background working with Change Controls and management of change control processes preferred.
+ Ability to solve problems with little guidance. Ability to identify the most efficient method to achieve predetermined objective. Ability to work effectively under pressure with constantly changing priorities and deadlines. Individuals may be required to sit, stand, walk regularly and occasionally lift to 15 lbs.; no lifting greater than 44.09 pounds without assistance. Specific vision requirements include reading of written documents and use of computer monitor screen frequently. Ability to work extended hours or off-hours as required.
**Why You Should Join Catalent**
+ Tuition Reimbursement - Let us help you finish your degree or earn a new one!
+ WellHub program to promote overall physical wellness.
+ 152 hours of PTO + 8 paid holidays.
+ Medical, dental and vision benefits effective day one of employment.
+ Defined career path and annual performance review and feedback process.
+ Diverse, inclusive culture. Several Employee Resource Groups focusing on D&I. Community engagement and green initiatives.
+ Dynamic, fast-paced work environment.
+ Positive working environment focusing on continually improving processes to remain innovative.
+ Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
+ Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.
**Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers ( to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE ( .
View Now
3
Intern - Regulatory Affairs
21214 Baltimore, Maryland
Labcorp
Posted today
Job Viewed
Job Description
Intern - Regulatory Affairs at Labcorp summary:
The Regulatory Affairs Intern at Labcorp supports compliance and regulatory activities for next generation sequencing (NGS) medical devices. Responsibilities include conducting scientific literature reviews, researching regulatory requirements for clinical trials, and assisting with submissions to regulatory authorities. The internship offers hands-on experience with global medical device regulations and opportunities to engage with leadership and professional development in a healthcare innovation environment.
Company Overview:
At Labcorp, we believe in the power of science to change lives. We are nearly 70,000 people across 100 countries who are harnessing science for human good. Our work combines unparalleled diagnostic laboratories, drug development capabilities and commercial innovations. Together, we fuel scientific breakthroughs and deliver more than 160 million medical test results that help guide treatment decisions, accelerate patient care and change lives.
Join us in our pursuit of answers.
Labcorp 2026 Global Internship Program Exciting Internship Opportunity – Regulatory Affairs Intern | Baltimore, MD!
Join Labcorp’s 2026 Global Internship Program and take the first step toward a meaningful career in healthcare innovation! We’re looking for motivated students to be part of a dynamic 11-week paid internship where you’ll work on impactful projects and gain real-world experience, all while supporting our mission to improve health and improve lives.
Internship 2026 Dates: June 1, 2026 – August 14, 2026
About the Program
As a Labcorp intern, you’ll be immersed in hands-on work that complements your academic background. In addition to your project work, you’ll gain valuable exposure to Labcorp’s global business, culture, and leadership through:
- Enterprise-wide learning experiences that introduce you to key business functions across Labcorp
- Leadership exposure and visibility , including direct interaction with senior leaders
- An immersive, in-person intern event June 2-4, 2026 designed to connect you with peers and deepen yourunderstanding of our mission
- Senior leader speaker sessions offering insights into strategy, innovation, and career growth
- Continuous opportunities to connect and grow, from intern cohort communication channels and LinkedInLearning resources to professional development sessions and storytelling opportunities that highlight yourinternship journey
- Connection to Labcorp’s inclusive culture through engagement with our employee resource groups (ERGs) and values-driven community initiatives
- Dedicated mentoring connections to guide your growth, provide career advice, and support your internship journey
Internship Details
- Duration: 11 weeks, full-time
- Dates of Internship: June 1, 2026 - August 14, 2026
- Location: Baltimore, MD
- Compensation: Paid internship; relocation assistance available for qualified candidates
- Eligibility: Preferred candidates are rising juniors and seniors (Dec 2026 through June 2028 graduation) who are currently enrolled in a relevant degree program; however, all current students pursuing related studiesare encouraged to apply.
Why Labcorp?
In 2025, we welcomed over 300 interns across our global offices. As part of the 2026 cohort, you’ll join a diverse community of future leaders working to shape the future of diagnostics, biopharmaceutical lab services, corporate functions, and healthcare delivery.
Ready to make a difference?
Apply now to launch your career and create real impact for patients worldwide. #FutureofLabcorp
About the Team:
The PGDx Regulatory and Quality Teams ensure the suitability, safety and effectiveness of next generation sequencing (NGS) medical devices that are developed, manufactured and distributed from our Baltimore, MD site.
Internship Assignment Summary:
- Review scientific literature review protocols, confirm processes and data sources.
- Execute literature reviews using scientific databases to identify relevant information about the NGS market, similar medical devices, competing technologies and other topics that will help PGDx identify new requirements and enhancements to ensure our NGS products remain state-of-the-art.
- Research genetic variants that could become clinically significant for therapies that will help treat cancer patients, as they relate to PGDx products.
- The RA intern will research requirements and processes to submit information about PGDx’s products to ethical committees and competent authorities to support clinical trials in the European Union.
- Become familiar with NGS technology, as well as US and global medical device requirements.
- Participate in regulatory body submissions and/or post-market surveillance data reporting.
- Perform related duties as assigned by supervisor.
- Maintain compliance with all company policies and procedures.
Education/Qualifications/Skills:
- Working towards Bachelor’s degree in Sciences or Biomedical Engineering, Public Health or Regulatory.
- Interested in genetics, biomedical engineering, cell biology and/or next generation sequencing.
- Looking for practical experience with US and global medical device quality and regulatory requirements.
- Interest in research and scientific literature.
- Can deliver results in an academic or professional setting.
- Ability to collaborate with various stakeholders and internal/external colleagues.
- This position is not eligible for visa sponsorship
Pay Range: $17 - $20/hr
All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here.
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.
Keywords:
regulatory affairs, next generation sequencing, medical devices, clinical trials, scientific literature review, biomedical engineering, genetic research, compliance, healthcare innovation, regulatory submissions
View Now
4
Intern - Regulatory Affairs
21276 Baltimore, Maryland
Labcorp
Posted today
Job Viewed
Job Description
Intern - Regulatory Affairs at Labcorp summary:
The Regulatory Affairs Intern at Labcorp supports compliance and regulatory activities for next generation sequencing (NGS) medical devices. Responsibilities include conducting scientific literature reviews, researching regulatory requirements for clinical trials, and assisting with submissions to regulatory authorities. The internship offers hands-on experience with global medical device regulations and opportunities to engage with leadership and professional development in a healthcare innovation environment.
Company Overview:
At Labcorp, we believe in the power of science to change lives. We are nearly 70,000 people across 100 countries who are harnessing science for human good. Our work combines unparalleled diagnostic laboratories, drug development capabilities and commercial innovations. Together, we fuel scientific breakthroughs and deliver more than 160 million medical test results that help guide treatment decisions, accelerate patient care and change lives.
Join us in our pursuit of answers.
Labcorp 2026 Global Internship Program Exciting Internship Opportunity – Regulatory Affairs Intern | Baltimore, MD!
Join Labcorp’s 2026 Global Internship Program and take the first step toward a meaningful career in healthcare innovation! We’re looking for motivated students to be part of a dynamic 11-week paid internship where you’ll work on impactful projects and gain real-world experience, all while supporting our mission to improve health and improve lives.
Internship 2026 Dates: June 1, 2026 – August 14, 2026
About the Program
As a Labcorp intern, you’ll be immersed in hands-on work that complements your academic background. In addition to your project work, you’ll gain valuable exposure to Labcorp’s global business, culture, and leadership through:
• Enterprise-wide learning experiences that introduce you to key business functions across Labcorp
• Leadership exposure and visibility , including direct interaction with senior leaders
• An immersive, in-person intern event June 2-4, 2026 designed to connect you with peers and deepen yourunderstanding of our mission
• Senior leader speaker sessions offering insights into strategy, innovation, and career growth
• Continuous opportunities to connect and grow, from intern cohort communication channels and LinkedInLearning resources to professional development sessions and storytelling opportunities that highlight yourinternship journey
• Connection to Labcorp’s inclusive culture through engagement with our employee resource groups (ERGs) and values-driven community initiatives
• Dedicated mentoring connections to guide your growth, provide career advice, and support your internship journey
Internship Details
• Duration: 11 weeks, full-time
• Dates of Internship: June 1,August 14, 2026
• Location: Baltimore, MD
• Compensation: Paid internship; relocation assistance available for qualified candidates
• Eligibility: Preferred candidates are rising juniors and seniors (Dec 2026 through June 2028 graduation) who are currently enrolled in a relevant degree program; however, all current students pursuing related studiesare encouraged to apply.
Why Labcorp?
In 2025, we welcomed over 300 interns across our global offices. As part of the 2026 cohort, you’ll join a diverse community of future leaders working to shape the future of diagnostics, biopharmaceutical lab services, corporate functions, and healthcare delivery.
Ready to make a difference?
Apply now to launch your career and create real impact for patients worldwide. #FutureofLabcorp
About the Team:
The PGDx Regulatory and Quality Teams ensure the suitability, safety and effectiveness of next generation sequencing (NGS) medical devices that are developed, manufactured and distributed from our Baltimore, MD site.
Internship Assignment Summary:
• Review scientific literature review protocols, confirm processes and data sources.
• Execute literature reviews using scientific databases to identify relevant information about the NGS market, similar medical devices, competing technologies and other topics that will help PGDx identify new requirements and enhancements to ensure our NGS products remain state-of-the-art.
• Research genetic variants that could become clinically significant for therapies that will help treat cancer patients, as they relate to PGDx products.
• The RA intern will research requirements and processes to submit information about PGDx’s products to ethical committees and competent authorities to support clinical trials in the European Union.
• Become familiar with NGS technology, as well as US and global medical device requirements.
• Participate in regulatory body submissions and/or post-market surveillance data reporting.
• Perform related duties as assigned by supervisor.
• Maintain compliance with all company policies and procedures.
Education/Qualifications/Skills:
• Working towards Bachelor’s degree in Sciences or Biomedical Engineering, Public Health or Regulatory.
• Interested in genetics, biomedical engineering, cell biology and/or next generation sequencing.
• Looking for practical experience with US and global medical device quality and regulatory requirements.
• Interest in research and scientific literature.
• Can deliver results in an academic or professional setting.
• Ability to collaborate with various stakeholders and internal/external colleagues.
• This position is not eligible for visa sponsorship
Pay Range: $17 - $20/hr
All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here .
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. A dditionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement .
Keywords:
regulatory affairs, next generation sequencing, medical devices, clinical trials, scientific literature review, biomedical engineering, genetic research, compliance, healthcare innovation, regulatory submissions
The Regulatory Affairs Intern at Labcorp supports compliance and regulatory activities for next generation sequencing (NGS) medical devices. Responsibilities include conducting scientific literature reviews, researching regulatory requirements for clinical trials, and assisting with submissions to regulatory authorities. The internship offers hands-on experience with global medical device regulations and opportunities to engage with leadership and professional development in a healthcare innovation environment.
Company Overview:
At Labcorp, we believe in the power of science to change lives. We are nearly 70,000 people across 100 countries who are harnessing science for human good. Our work combines unparalleled diagnostic laboratories, drug development capabilities and commercial innovations. Together, we fuel scientific breakthroughs and deliver more than 160 million medical test results that help guide treatment decisions, accelerate patient care and change lives.
Join us in our pursuit of answers.
Labcorp 2026 Global Internship Program Exciting Internship Opportunity – Regulatory Affairs Intern | Baltimore, MD!
Join Labcorp’s 2026 Global Internship Program and take the first step toward a meaningful career in healthcare innovation! We’re looking for motivated students to be part of a dynamic 11-week paid internship where you’ll work on impactful projects and gain real-world experience, all while supporting our mission to improve health and improve lives.
Internship 2026 Dates: June 1, 2026 – August 14, 2026
About the Program
As a Labcorp intern, you’ll be immersed in hands-on work that complements your academic background. In addition to your project work, you’ll gain valuable exposure to Labcorp’s global business, culture, and leadership through:
• Enterprise-wide learning experiences that introduce you to key business functions across Labcorp
• Leadership exposure and visibility , including direct interaction with senior leaders
• An immersive, in-person intern event June 2-4, 2026 designed to connect you with peers and deepen yourunderstanding of our mission
• Senior leader speaker sessions offering insights into strategy, innovation, and career growth
• Continuous opportunities to connect and grow, from intern cohort communication channels and LinkedInLearning resources to professional development sessions and storytelling opportunities that highlight yourinternship journey
• Connection to Labcorp’s inclusive culture through engagement with our employee resource groups (ERGs) and values-driven community initiatives
• Dedicated mentoring connections to guide your growth, provide career advice, and support your internship journey
Internship Details
• Duration: 11 weeks, full-time
• Dates of Internship: June 1,August 14, 2026
• Location: Baltimore, MD
• Compensation: Paid internship; relocation assistance available for qualified candidates
• Eligibility: Preferred candidates are rising juniors and seniors (Dec 2026 through June 2028 graduation) who are currently enrolled in a relevant degree program; however, all current students pursuing related studiesare encouraged to apply.
Why Labcorp?
In 2025, we welcomed over 300 interns across our global offices. As part of the 2026 cohort, you’ll join a diverse community of future leaders working to shape the future of diagnostics, biopharmaceutical lab services, corporate functions, and healthcare delivery.
Ready to make a difference?
Apply now to launch your career and create real impact for patients worldwide. #FutureofLabcorp
About the Team:
The PGDx Regulatory and Quality Teams ensure the suitability, safety and effectiveness of next generation sequencing (NGS) medical devices that are developed, manufactured and distributed from our Baltimore, MD site.
Internship Assignment Summary:
• Review scientific literature review protocols, confirm processes and data sources.
• Execute literature reviews using scientific databases to identify relevant information about the NGS market, similar medical devices, competing technologies and other topics that will help PGDx identify new requirements and enhancements to ensure our NGS products remain state-of-the-art.
• Research genetic variants that could become clinically significant for therapies that will help treat cancer patients, as they relate to PGDx products.
• The RA intern will research requirements and processes to submit information about PGDx’s products to ethical committees and competent authorities to support clinical trials in the European Union.
• Become familiar with NGS technology, as well as US and global medical device requirements.
• Participate in regulatory body submissions and/or post-market surveillance data reporting.
• Perform related duties as assigned by supervisor.
• Maintain compliance with all company policies and procedures.
Education/Qualifications/Skills:
• Working towards Bachelor’s degree in Sciences or Biomedical Engineering, Public Health or Regulatory.
• Interested in genetics, biomedical engineering, cell biology and/or next generation sequencing.
• Looking for practical experience with US and global medical device quality and regulatory requirements.
• Interest in research and scientific literature.
• Can deliver results in an academic or professional setting.
• Ability to collaborate with various stakeholders and internal/external colleagues.
• This position is not eligible for visa sponsorship
Pay Range: $17 - $20/hr
All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here .
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. A dditionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement .
Keywords:
regulatory affairs, next generation sequencing, medical devices, clinical trials, scientific literature review, biomedical engineering, genetic research, compliance, healthcare innovation, regulatory submissions
View Now
5
Intern - Regulatory Affairs
21276 Baltimore, Maryland
Labcorp
Posted today
Job Viewed
Job Description
Intern - Regulatory Affairs at Labcorp summary:
The Regulatory Affairs Intern at Labcorp supports compliance and regulatory activities for next generation sequencing (NGS) medical devices. Responsibilities include conducting scientific literature reviews, researching regulatory requirements for clinical trials, and assisting with submissions to regulatory authorities. The internship offers hands-on experience with global medical device regulations and opportunities to engage with leadership and professional development in a healthcare innovation environment.
Company Overview:
At Labcorp, we believe in the power of science to change lives. We are nearly 70,000 people across 100 countries who are harnessing science for human good. Our work combines unparalleled diagnostic laboratories, drug development capabilities and commercial innovations. Together, we fuel scientific breakthroughs and deliver more than 160 million medical test results that help guide treatment decisions, accelerate patient care and change lives.
Join us in our pursuit of answers.
Labcorp 2026 Global Internship Program Exciting Internship Opportunity – Regulatory Affairs Intern | Baltimore, MD!
Join Labcorp’s 2026 Global Internship Program and take the first step toward a meaningful career in healthcare innovation! We’re looking for motivated students to be part of a dynamic 11-week paid internship where you’ll work on impactful projects and gain real-world experience, all while supporting our mission to improve health and improve lives.
Internship 2026 Dates: June 1, 2026 – August 14, 2026
About the Program
As a Labcorp intern, you’ll be immersed in hands-on work that complements your academic background. In addition to your project work, you’ll gain valuable exposure to Labcorp’s global business, culture, and leadership through:
• Enterprise-wide learning experiences that introduce you to key business functions across Labcorp
• Leadership exposure and visibility , including direct interaction with senior leaders
• An immersive, in-person intern event June 2-4, 2026 designed to connect you with peers and deepen yourunderstanding of our mission
• Senior leader speaker sessions offering insights into strategy, innovation, and career growth
• Continuous opportunities to connect and grow, from intern cohort communication channels and LinkedInLearning resources to professional development sessions and storytelling opportunities that highlight yourinternship journey
• Connection to Labcorp’s inclusive culture through engagement with our employee resource groups (ERGs) and values-driven community initiatives
• Dedicated mentoring connections to guide your growth, provide career advice, and support your internship journey
Internship Details
• Duration: 11 weeks, full-time
• Dates of Internship: June 1,August 14, 2026
• Location: Baltimore, MD
• Compensation: Paid internship; relocation assistance available for qualified candidates
• Eligibility: Preferred candidates are rising juniors and seniors (Dec 2026 through June 2028 graduation) who are currently enrolled in a relevant degree program; however, all current students pursuing related studiesare encouraged to apply.
Why Labcorp?
In 2025, we welcomed over 300 interns across our global offices. As part of the 2026 cohort, you’ll join a diverse community of future leaders working to shape the future of diagnostics, biopharmaceutical lab services, corporate functions, and healthcare delivery.
Ready to make a difference?
Apply now to launch your career and create real impact for patients worldwide. #FutureofLabcorp
About the Team:
The PGDx Regulatory and Quality Teams ensure the suitability, safety and effectiveness of next generation sequencing (NGS) medical devices that are developed, manufactured and distributed from our Baltimore, MD site.
Internship Assignment Summary:
• Review scientific literature review protocols, confirm processes and data sources.
• Execute literature reviews using scientific databases to identify relevant information about the NGS market, similar medical devices, competing technologies and other topics that will help PGDx identify new requirements and enhancements to ensure our NGS products remain state-of-the-art.
• Research genetic variants that could become clinically significant for therapies that will help treat cancer patients, as they relate to PGDx products.
• The RA intern will research requirements and processes to submit information about PGDx’s products to ethical committees and competent authorities to support clinical trials in the European Union.
• Become familiar with NGS technology, as well as US and global medical device requirements.
• Participate in regulatory body submissions and/or post-market surveillance data reporting.
• Perform related duties as assigned by supervisor.
• Maintain compliance with all company policies and procedures.
Education/Qualifications/Skills:
• Working towards Bachelor’s degree in Sciences or Biomedical Engineering, Public Health or Regulatory.
• Interested in genetics, biomedical engineering, cell biology and/or next generation sequencing.
• Looking for practical experience with US and global medical device quality and regulatory requirements.
• Interest in research and scientific literature.
• Can deliver results in an academic or professional setting.
• Ability to collaborate with various stakeholders and internal/external colleagues.
• This position is not eligible for visa sponsorship
Pay Range: $17 - $20/hr
All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here .
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. A dditionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement .
Keywords:
regulatory affairs, next generation sequencing, medical devices, clinical trials, scientific literature review, biomedical engineering, genetic research, compliance, healthcare innovation, regulatory submissions
The Regulatory Affairs Intern at Labcorp supports compliance and regulatory activities for next generation sequencing (NGS) medical devices. Responsibilities include conducting scientific literature reviews, researching regulatory requirements for clinical trials, and assisting with submissions to regulatory authorities. The internship offers hands-on experience with global medical device regulations and opportunities to engage with leadership and professional development in a healthcare innovation environment.
Company Overview:
At Labcorp, we believe in the power of science to change lives. We are nearly 70,000 people across 100 countries who are harnessing science for human good. Our work combines unparalleled diagnostic laboratories, drug development capabilities and commercial innovations. Together, we fuel scientific breakthroughs and deliver more than 160 million medical test results that help guide treatment decisions, accelerate patient care and change lives.
Join us in our pursuit of answers.
Labcorp 2026 Global Internship Program Exciting Internship Opportunity – Regulatory Affairs Intern | Baltimore, MD!
Join Labcorp’s 2026 Global Internship Program and take the first step toward a meaningful career in healthcare innovation! We’re looking for motivated students to be part of a dynamic 11-week paid internship where you’ll work on impactful projects and gain real-world experience, all while supporting our mission to improve health and improve lives.
Internship 2026 Dates: June 1, 2026 – August 14, 2026
About the Program
As a Labcorp intern, you’ll be immersed in hands-on work that complements your academic background. In addition to your project work, you’ll gain valuable exposure to Labcorp’s global business, culture, and leadership through:
• Enterprise-wide learning experiences that introduce you to key business functions across Labcorp
• Leadership exposure and visibility , including direct interaction with senior leaders
• An immersive, in-person intern event June 2-4, 2026 designed to connect you with peers and deepen yourunderstanding of our mission
• Senior leader speaker sessions offering insights into strategy, innovation, and career growth
• Continuous opportunities to connect and grow, from intern cohort communication channels and LinkedInLearning resources to professional development sessions and storytelling opportunities that highlight yourinternship journey
• Connection to Labcorp’s inclusive culture through engagement with our employee resource groups (ERGs) and values-driven community initiatives
• Dedicated mentoring connections to guide your growth, provide career advice, and support your internship journey
Internship Details
• Duration: 11 weeks, full-time
• Dates of Internship: June 1,August 14, 2026
• Location: Baltimore, MD
• Compensation: Paid internship; relocation assistance available for qualified candidates
• Eligibility: Preferred candidates are rising juniors and seniors (Dec 2026 through June 2028 graduation) who are currently enrolled in a relevant degree program; however, all current students pursuing related studiesare encouraged to apply.
Why Labcorp?
In 2025, we welcomed over 300 interns across our global offices. As part of the 2026 cohort, you’ll join a diverse community of future leaders working to shape the future of diagnostics, biopharmaceutical lab services, corporate functions, and healthcare delivery.
Ready to make a difference?
Apply now to launch your career and create real impact for patients worldwide. #FutureofLabcorp
About the Team:
The PGDx Regulatory and Quality Teams ensure the suitability, safety and effectiveness of next generation sequencing (NGS) medical devices that are developed, manufactured and distributed from our Baltimore, MD site.
Internship Assignment Summary:
• Review scientific literature review protocols, confirm processes and data sources.
• Execute literature reviews using scientific databases to identify relevant information about the NGS market, similar medical devices, competing technologies and other topics that will help PGDx identify new requirements and enhancements to ensure our NGS products remain state-of-the-art.
• Research genetic variants that could become clinically significant for therapies that will help treat cancer patients, as they relate to PGDx products.
• The RA intern will research requirements and processes to submit information about PGDx’s products to ethical committees and competent authorities to support clinical trials in the European Union.
• Become familiar with NGS technology, as well as US and global medical device requirements.
• Participate in regulatory body submissions and/or post-market surveillance data reporting.
• Perform related duties as assigned by supervisor.
• Maintain compliance with all company policies and procedures.
Education/Qualifications/Skills:
• Working towards Bachelor’s degree in Sciences or Biomedical Engineering, Public Health or Regulatory.
• Interested in genetics, biomedical engineering, cell biology and/or next generation sequencing.
• Looking for practical experience with US and global medical device quality and regulatory requirements.
• Interest in research and scientific literature.
• Can deliver results in an academic or professional setting.
• Ability to collaborate with various stakeholders and internal/external colleagues.
• This position is not eligible for visa sponsorship
Pay Range: $17 - $20/hr
All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here .
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. A dditionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement .
Keywords:
regulatory affairs, next generation sequencing, medical devices, clinical trials, scientific literature review, biomedical engineering, genetic research, compliance, healthcare innovation, regulatory submissions
View Now
Be The First To Know
About the latest Professional standards Jobs in United States !
6