2,068 Social Governance jobs in the United States
Intern - Regulatory Affairs
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
Intern - Regulatory Affairs
Posted today
Job Viewed
Job Description
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
Intern - Regulatory Affairs
Posted today
Job Viewed
Job Description
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
Regulatory Affairs Coordinator
Posted today
Job Viewed
Job Description
Bridor North America is expanding rapidly in the U.S. market, bringing world-class, European-inspired baked goods to customers across retail, foodservice, and industrial channels. As part of this growth, we're seeking a detail-oriented Regulatory Affairs Coordinator to join our Salt Lake City team. This role is key to ensuring that all finished product documentation - including labels, specifications, and certifications - complies with food safety and quality regulations across Canada, the United States, and export markets.
You'll play a vital cross-functional role, supporting new product development and market entry through regulatory expertise, technical documentation, and collaborative compliance work.
Key Responsibilities
- Ensure ingredient, allergen, and physical specs meet Canadian, U.S., and international regulations
- Review and validate all change requests for compliance impacts
- Maintain technical documentation for co-packers and third-party manufacturers
- Keep data current in ERP systems and customer portals
- Create compliant ingredient lists and nutrition tables using Genesis software
- Approve packaging components in line with regulatory and client standards
- Review and validate product claims (e.g., non-GMO, clean label, kosher)
- Ensure accuracy of technical and marketing materials
- Act as a regulatory resource for Quality, R&D, Sales, and Marketing teams
- Support sales with required documentation and technical responses
- Attend interdepartmental meetings as the regulatory representative
- Monitor changes in Canadian and international food regulations
- Proactively flag and mitigate compliance risks
- Coordinate specification reviews and manage label templates
- Support audit readiness and maintain customer requirement documentation
- Education: Associate degree in Food Technology or equivalent
- Experience: Minimum 3-5 years in food regulatory affairs or a related compliance role
- Languages: Bilingual in English and Spanish (written and spoken)
- Regulatory Knowledge: Familiar with CFIA, FDA, and USDA regulatory frameworks
- Exceptional attention to detail with strong documentation and synthesis skills
- Diplomacy and professionalism in client communication
- Strong organizational skills with the ability to multitask and meet deadlines
- Ability to work independently and collaboratively in cross-functional settings
- Proficient in Microsoft Office Suite (especially Excel and Word)
- Comfortable managing technical data in ERP systems and label software platforms
- Bachelor's degree in Food Science or a related field
- Experience with Genesis and Bartender software
- Working knowledge of BRCGS, FSMA, and other global food safety standards
- Experience with basic statistical analysis for technical documentation
Why Join Bridor?
At Bridor, we blend artisanal quality with cutting-edge food manufacturing, bringing authentic baked goods to market with an unwavering commitment to quality and compliance. As Bridor North America expands its U.S. operations, this is an exciting opportunity to join a growing team with clear vision, values, and momentum. You'll have direct impact on compliance, innovation, and customer trust in a dynamic, collaborative environment.
Ready to make a difference through compliance excellence?
Apply today to join our Salt Lake City team and help shape the future of food safety and innovation.
Regulatory Affairs Internship
Posted today
Job Viewed
Job Description
Overview
Launch your career with Kemin Industries as a Regulatory Affairs Intern!
Are you ready to make a real impact this summer? Kemin Industries is now accepting applications for our 2026 Regulatory Affairs Internships—a dynamic, hands-on experience designed to accelerate your growth and ignite your future.
What to Expect:
10–12 Week Program: Dive into a full-time internship where you'll tackle a meaningful project that directly contributes to Kemin's mission and operations.
Presentation: Showcase your work and insights to Kemin team members—including our executive leadership—at the end of the program.
Mentorship & Career Development: Receive personalized guidance from experienced professionals who are invested in your success, both now and beyond graduation.
Beyond the Office: We believe great ideas come from well-rounded experiences. That's why we offer a variety of networking events, social gatherings, and team-building activities to help you connect, collaborate, and have fun along the way.
Ready to Make Your Mark?If you're passionate about innovation, eager to learn, and excited to contribute to a global company making a difference, we'd love to hear from you!
Join the Kemin Team and Transform Lives!
We are a privately held, family-owned-and-operated global biotechnology company driven by curiosity and committed to transforming the quality of life for people, pets, and the planet.
We create solutions that strengthen health and wellbeing, provide nutrition and immune support for pets and production animals, safeguard the planet's natural resources, and protect the global food supply chain for generations to come.
We supply over 500 specialty ingredients for various industries, including human and animal health and nutrition, pet food, aquaculture, nutraceutical, food technologies, crop technologies, textiles, biofuels, and animal vaccines.
We employ 3,500 global employees and operations in 90 countries, including manufacturing facilities in Belgium, Brazil, China, Egypt, India, Italy, San Marino, Singapore, South Africa, and the United States.
Responsibilities
Spearhead a summer project that will leave a lasting impact.
Assist with various tasks within your team.
Participate in department meetings and contribute ideas regularly.
Liaison with other departments regarding work and initiatives.
Identify process improvements and create standard work.
Partake in the Kemin Summer Internship Program events and trainings.
Prepare and give a final presentation to Kemin Industries leadership.
Qualifications
Currently enrolled as a freshman, sophomore, junior, or senior with an accredited college or university, pursuing a degree in Pre-Law, or a Science related field; Animal Science, Food Science, Chemistry, or Biology.
Ability to commit to 10-12 weeks of on-site, full time employment during the months of May-August 2026.
Excellent written and oral communication skills.
A high level of passion for your field of study.
A post-offer background check and drug screen is required. Additional pre-employment requirements may be necessary based on position.
Kemin is an equal opportunity employer, and all reasonable accommodations will be considered. Kemin is a drug-free and tobacco-free campus.
#LI-MN1
LocationUS-IA-Des Moines
Posted Date1 month ago(9/8/ :21 PM)
Job ID
Positions 0Category Corporate Engineering
Position Type Intern (Full Time)
Regulatory Affairs Specialist
Posted today
Job Viewed
Job Description
Level
Experienced
Job Location
Warrington, PA
Position Type
Full Time
Education Level
4 Year Degree
Salary Range
$ - $ Salary
Travel Percentage
Negligible
Job Shift
M-F / 1st shift
Job Category
Manufacturing
Description
The Regulatory Affairs Specialist is responsible for ensuring compliance with applicable regulatory requirements, including 21 CFR Part 820 GMP, ISO 13485:2016, and other international standards. This role will support product development, registration, and post-market activities to ensure Polysciences, Inc. & Kyfora Bio LLC products meet all regulatory, safety, compliance and quality requirements. This position is 100% onsite .
Essential Functions:
Provide regulatory guidance during new product design and development to ensure compliance with applicable standards and regulations.
- Prepare, review, and submit regulatory documentation for Drug Master Files, product approvals, registrations, and renewals (e.g., FDA submissions).
- Maintain compliance with 21 CFR Part 820 GMP, ISO 13485:2016 , and other relevant quality system requirements.
- Support external audits, including supplier audits, customer audits, FDA inspections and Notified Body audits.
- Conducts Internal Audits and maintains the Internal Audit system.
- Ensure product labeling, packaging, and promotional materials meet regulatory requirements.
- Monitor and assess regulatory changes, guiding cross-functional teams on potential impacts.
- Collaborate with R&D, Quality, Sales, Marketing, and Manufacturing and other applicable departments to ensure regulatory compliance throughout the product lifecycle.
- Participate in risk management activities, including design controls, change control, and NC/CAPA processes.
- Maintain regulatory records, databases, and documentation to support audits and inspections.
- Conduct regulatory gap assessments on products and implement necessary actions to address the identified gaps.
- Quality Agreement review and interpretation for QA Management approval.
Qualifications
Education Required : Bachelor's Degree
Certification(s):
Auditor training required.
Lead Auditor Certification preferred.
Regulatory Affairs Certification (RAC) or Regulatory Compliance Certification (RCC) preferred.
Computer Skills Required:
Proficiency with document management software and Microsoft Office Suite.
Preferred experience with Enterprise Resource Planning (ERP) systems for tracking suppliers, materials, and customer complaints.
Preferred experience with electronic QMS systems for tracking and reviewing documents, training, quality issues, CAPA, effectiveness checks, and change controls.
Other qualifications:
- 3+ years of regulatory affairs experience in a medical device or pharmaceutical manufacturing environment .
- In-depth knowledge of 21 CFR Part 820 and ISO 13485:2016 .
- Knowledge of 21 CFR Part 210,211 requirements preferred.
- Strong understanding of design controls, risk management, and product lifecycle requirements.
- Excellent organizational, communication, and technical writing skills.
- Ability to work cross-functionally and manage multiple priorities in a fast-paced environment.
- Familiarity with REACH, EU MDR, MDSAP, and international regulatory pathways is a plus.
- Experience with Good Manufacturing Practices (GMP)
- Strong analytical and problem-solving abilities.
- Highly organized and detail-oriented, with the ability to manage multiple tasks, systems and projects simultaneously.
- Experience with SAP preferred.
- Strong written and verbal communication skills to interact effectively with various departments, such as Quality, Operations, and Engineering.
- Experience with audit preparedness and support during internal and external audits.
Regulatory Affairs Consultant
Posted today
Job Viewed
Job Description
Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job.
Regulatory Affairs Specialist must have Bachelors Degree in Chemistry, Biology, Toxicology or related field
Regulatory Affairs Specialist requires:
- Experience in professional level position in business
- Experience with OSHA/TSCA/RCRA/Export regulations
- Ability to manage multiple projects while effectively communicating status to senior staff
- Ensure customers and employees are fully informed about the health and safety characteristics of our products and raw materials
- Provide timely assessments of developmental materials, including chemical materials and formulations,
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