Regulatory roles across the United States present many career opportunities for professionals with compliance and legal expertise. These positions span various industries, including finance, healthcare, pharmaceuticals, and technology, requiring skills in risk management, policy interpretation, and quality control. Job seekers can find positions such as 3,541 Regulatory jobs in the United States
Regulatory Affairs
Posted 2 days ago
Job Viewed
Job Description
Join to apply for the Regulatory Affairs role at Planet Pharma 2 days ago Be among the first 25 applicants Join to apply for the Regulatory Affairs role at Planet Pharma Get AI-powered advice on this job and more exclusive features. Job Duties And Qualifications Individual contributor who is fully proficient in applying subject matter knowledge for a professional discipline. Works under limited supervision. Description Job Description Job Duties And Qualifications Individual contributor who is fully proficient in applying subject matter knowledge for a professional discipline. Works under limited supervision. Essential Functions Acts as a Regulatory Team Leader on more complex projects, which may include technical writing; Prepares and/or reviews regulatory documentation in area of expertise, as appropriate; Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments; Acts as an SME/ expert in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable; Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate; May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development; May present to clients on complex regulatory processes at large full service bid defense meetings by phone or in person; May act as reviewer for regulatory standard operating procedures, as assigned and appropriate; May prepare and deliver regulatory training to IQVIA small groups or individuals; Performs other tasks or assignments, as delegated by Regulatory management; Qualifications Bachelor's Degree Degree in Lifescience or related discipline Req Or Master's Degree Degree in Lifescience or related discipline Req At least 3-4 years relevant experience Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate; Possesses a specific regulatory or technical expertise; Good, solid interpersonal communication (oral and written) and organisation skills; Ability to establish and maintain effective working relationships with coworkers, managers and clients; Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable; Demonstrates self-motivation and enthusiasm; Ability to work on several projects, with direction from senior staff as appropriate; Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements; Ability to make decisions on discrete tasks under senior supervision; Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education; Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area; Problems faced are general and may require understanding of broader set of issues, but typically are not complex; Ability to adapt quickly to a rapidly changing environment; Pay Rate Range: $30-38/hr depending on experience The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Seniority level Seniority level Not Applicable Employment type Employment type Full-time Job function Job function Legal Industries Staffing and Recruiting Referrals increase your chances of interviewing at Planet Pharma by 2x Sign in to set job alerts for “Regulatory Affairs Specialist” roles. Regulatory & Study Start Up Specialist II Accreditation, Regulatory, and Licensing Specialist V, Clinical (KFHP/H) Accreditation, Regulatory, and Licensing Specialist V, Clinical (KFHP/H) Quality & Safety Oversight Specialist V, Clinical Quality Oversight (KFHP/H) Director, Accreditation, Regulatory and Clinical Quality Assurance Specialist-Core Laboratory Suitland, MD $16,499.60- 145,624.50 2 weeks ago Quality Assurance Complaints Handling Specialist Corporate Attorney - Regulatory / Maryland Quality Assurance Specialist -Laboratory (Surgical Pathology Lab) Director, Accreditation, Regulatory and Clinical We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Regulatory Affairs
Posted 3 days ago
Job Viewed
Job Description
Description:
Job Duties and Qualifications
Individual contributor who is fully proficient in applying subject matter knowledge for a professional discipline. Works under limited supervision.
Essential Functions
• Acts as a Regulatory Team Leader on more complex projects, which may include technical writing;
• Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;
• Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments;
• Acts as an SME/ expert in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable;
• Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate;
• May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development;
• May present to clients on complex regulatory processes at large full service bid defense meetings by phone or in person;
• May act as reviewer for regulatory standard operating procedures, as assigned and appropriate;
• May prepare and deliver regulatory training to IQVIA small groups or individuals;
• Performs other tasks or assignments, as delegated by Regulatory management;
Qualifications
• Bachelor's Degree Degree in Lifescience or related discipline Req Or
• Master's Degree Degree in Lifescience or related discipline Req
• At least 3-4 years relevant experience
• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;
• Possesses a specific regulatory or technical expertise;
• Good, solid interpersonal communication (oral and written) and organisation skills;
• Ability to establish and maintain effective working relationships with coworkers, managers and clients;
• Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable;
• Demonstrates self-motivation and enthusiasm;
• Ability to work on several projects, with direction from senior staff as appropriate;
• Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements;
• Ability to make decisions on discrete tasks under senior supervision;
• Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education;
• Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;
• Problems faced are general and may require understanding of broader set of issues, but typically are not complex;
• Ability to adapt quickly to a rapidly changing environment;
Pay Rate Range: $30-38/hr depending on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Regulatory Affairs
Posted 6 days ago
Job Viewed
Job Description
We are currently seeking a detail-oriented and motivated Regulatory Affairs Specialist. This role is crucial in ensuring that our products comply with all regulatory requirements. If you are passionate about regulatory affairs and looking for an opportunity to grow within a dynamic company, we encourage you to apply.
Responsibilities:
- Prepare, review, and submit regulatory documents to ensure compliance with FDA and other regulatory authorities.
- Maintain up-to-date knowledge of regulations, guidelines, and standards relevant to the pharmaceutical industry.
- Assist in the preparation of regulatory submissions including New Drug Applications (NDAs), Investigational New Drug Applications (INDs), and amendments.
- Coordinate with cross-functional teams to gather necessary information for regulatory submissions.
- Ensure timely and accurate communication with regulatory authorities.
- Monitor and track the progress of submissions and respond to any inquiries from regulatory bodies.
- Assist in the development and implementation of regulatory strategies to support product approvals and lifecycle management.
- Maintain accurate and organized regulatory files and records.
- Bachelor's degree in a related field such as biology, chemistry, or pharmaceutical sciences.
- Previous experience in a regulatory affairs role within the pharmaceutical industry is preferred.
- Strong understanding of FDA regulations and guidelines.
- Excellent organizational and time management skills.
- Strong attention to detail and ability to handle multiple projects simultaneously.
- Effective communication skills, both written and verbal.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Ability to work independently and as part of a team.
Regulatory Affairs Consultant
Posted today
Job Viewed
Job Description
1. Should have experience in eCTD, NeeS, and paper formats. 2. Working experience in all major emerging countries (EU, GCC, US, ASEAN, etc.). 3. Responsible for compilation, publishing, and technical quality control of regulatory submissions, including technical troubleshooting to ensure issues are resolved and deadlines are met. 4. Should have experience in handling submission gateway sites. Experience: 5-8 years #J-18808-Ljbffr
Regulatory Affairs Specialist
Posted today
Job Viewed
Job Description
Regulatory Affairs Specialist page is loaded
Regulatory Affairs Specialist Apply locations USA, Georgia, Atlanta USA, Texas, Houston time type Full time posted on Posted 3 Days Ago job requisition id R0029951Job Description:
At Enovis we pay attention to the details. We embrace collaboration with our partners and patients, and take pride in the pursuit of scientific excellence with the goal of transforming medical technology as we know it.
Because thats how we change the lives of patients for the better. And thats how we create better together. Why work at Enovis? See for yourself .
Job Title :
Regulatory Affairs Specialist
Reports To :
Director, Regulatory Affairs | Foot & Ankle
Location:
Atlanta, GA or Houston, TX
Business Unit Description :
Regulatory Affairs
High-Level Position Summary :
We are seeking a skilled and experienced Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist will be supporting a wide range of regulatory activities to ensure compliance with global submission requirements, departmental processes, and quality system standards. This role will develop regulatory strategies, complete impact assessments, and prepare submissions including U.S. FDA 510(k)s, EU MDR Technical Documentation and other OUS registrations. The RA Specialist will support the Foot & Ankle Business Unit (F&A BU), contribute to new product development and sustaining projects, and engage with global regulatory authorities including the FDA and EU Notified Body.
Key Responsibilities
The following are the primary duties and responsibilities of this role. Other related duties may be assigned to meet the business need.
- Provide regulatory expertise and guidance to cross-functional teams for both new product development and sustaining projects.
- Complete regulatory deliverables for assigned projects, including strategy development, impact assessments, and submission preparation through to clearance or approval.
- Prepare global submissions including but not limited to U.S. FDA 510(k) Premarket Notifications, PMA submissions, EU MDR Technical Documentation, and other international product registrations
- Collaborate with cross-functional teams to collect and review technical documentation, ensuring accuracy, regulatory compliance, and timely submissions.
- Communicate and negotiate with global regulatory bodies during submission reviews, audits, and post-market activities.
- Identify risks and develop contingency plans for assigned regulatory projects.
- Interpret and communicate regulatory requirements and guidance to internal teams and stakeholders.
- Maintain regulatory databases, trackers, and documentation in accordance with internal procedures and applicable regulations.
- Support compliance-related activities such as site registrations, audits, and post-market surveillance (e.g., HHEs, MDRs, FAs, CAPAs).
- Apply quality system knowledge to all job functions.
- Perform additional tasks as assigned by the Regulatory Manager.
- Comply with Enovis's Code of Conduct, company policies, procedures, and standards.
Currently, Enovis does not provide sponsorship for employment visas (e.g., H-1B) and will not offer such sponsorship in the future. Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.
Minimum Basic Qualifications:
- Bachelors degree in a scientific discipline (e.g., biology, microbiology, chemistry, engineering, or medical technology).
- Minimum 5 years of regulatory affairs experience in the medical device industry.
- Proven experience preparing U.S. FDA 510(k) submissions.
- Strong understanding of design and change control processes, regulatory assessments, and quality system requirements under ISO 13485 and FDA QSR.
- Experience working cross-functionally and with regulatory agencies.
Desired Characteristics :
- Experience with international registrations and submissions including EU MDR.
- Knowledge of medical device labeling and associated regulations.
- High attention to detail with a focus on accuracy and completeness.
- Strong written and verbal communication skills.
- Excellent organizational, planning, and time management abilities.
- Analytical and problem-solving mindset.
- Strong interpersonal and team collaboration skills.
- Ability to work independently with minimal supervision.
- Adaptable, proactive, and capable of leading regulatory initiatives.
- Proficient in Microsoft Office, Adobe Acrobat, and Agile PLM systems.
Travel: 10%
Work environment | Physical demands:
Ability to sit and stand for long periods of time.
Work schedule:
Hybrid schedule is available with three days on-site.
Creating better together. Its the Enovis purpose, and its what drives us and empowers us every day on a global scale. We know that the power to create better for our customers, our team members, and our shareholders begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.
Watch this short on creating the next generation of better together at Enovis:
Better is. | Enovis
We offer a comprehensive benefits package which includes:
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Spending and Savings Accounts
- 401(k) Plan
- Vacation, Sick Leave, and Holidays
- Income Protection Plans
- Discounted Insurance Rates
- Legal Services
ABOUT ENOVIS
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent, and innovation, the Companys extensive range of products, services, and integrated technologies fuels active lifestyles in orthopedics and beyond. Visit to learn more.
EQUAL EMPLOYMENT OPPORTUNITY:
Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.
ABOUT ENOVIS
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Companys extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond.For more information about Enovis, please visit .
EOE AA M/F/VET/Disability Statement
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.
About UsEnovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Companys extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit .
#J-18808-LjbffrQuality & Regulatory Affairs
Posted today
Job Viewed
Job Description
Quality and regulatory affairs teams guard the safety of how a company operates and what it produces. Those who hold such positions have the opportunity to use their expertise for the good of others. At Danaher, quality and regulatory affairs jobs lead the way for a better tomorrow for humanity. We pioneer the future of science and technology to solve the world's most complex challenges. Our passion and dedication to this work bring a positive impact inside the company and all over the world. Maintain High Quality Standards A job in quality assurance or regulatory affairs means looking out for a company and the people it serves. In the scientific and health world, these jobs hold special significance. High quality means the right diagnosis or a successful medical procedure. The work focuses on meeting strict guidelines for safety and ethics. By following these regulations, quality and regulatory affairs teams ensure products work effectively. These products promote the safety of patients. In an international market, compliance professionals serve an even more significant role, navigating the complex and ever-changing rules of different countries to deliver consistent positive outcomes. Quality and regulatory affairs jobs also focus on keeping accurate records. These records clearly show how a company works, giving patients peace of mind. Advance Life-Changing Science and Technology Quality and regulatory affairs jobs at Danaher mean protecting customers and patients by providing innovative products that meet regulatory standards. As a company seeking to deliver innovation at the speed of life, we rely on regulatory experts. These professionals keep us improving and promote better results. A job in quality assurance or regulatory affairs means uniting teams under a common mindset and set of rules to create quality products that customers feel confident using. The work of these experts includes: Implementing quality management systems Overseeing adherence to applicable laws Establishing regulatory strategies Quality and regulatory affairs experts accomplish these tasks through audits, inspections and risk assessments. Their expert work accelerates ideas to impact by creating streamlined quality assurance processes. Danaher offers quality and regulatory affairs jobs around the world. We operate in countries like India, the United States, Sweden, Singapore and Germany. Over 15 operating companies within Danaher offer plenty of opportunities for advancing careers while making a difference in the world. The positions we offer range from intern and entry-level to specialist and management roles. Change the World With Danaher A career in quality and regulatory affairs at Danaher means unlocking access to innovation. Our jobs in this field mean watching out for quality in the work we do and the products we create, leading to positive impacts around the globe. A career at Danaher also provides individual benefits, including: Competitive benefits that care for physical, financial and emotional needs Career development opportunities through the Danaher Business System (DBS) A workplace that fosters diversity, equity and inclusion Explore Our Regulatory Affairs and Quality Assurance Jobs A job in quality assurance or regulatory affairs means looking out for a company and the people it serves. In the scientific and health world, these jobs hold special significance. High quality means the right diagnosis or a successful medical procedure. The work focuses on meeting strict guidelines for safety and ethics. By following these regulations, quality and regulatory affairs teams ensure products work effectively. These products promote the safety of patients. In an international market, compliance professionals serve an even more significant role, navigating the complex and ever-changing rules of different countries to deliver consistent positive outcomes. Quality and regulatory affairs jobs also focus on keeping accurate records. These records clearly show how a company works, giving patients peace of mind. Advance Life-Changing Science and Technology Quality and regulatory affairs jobs at Danaher mean protecting customers and patients by providing innovative products that meet regulatory standards. As a company seeking to deliver innovation at the speed of life, we rely on regulatory experts. These professionals keep us improving and promote better results. A job in quality assurance or regulatory affairs means uniting teams under a common mindset and set of rules to create quality products that customers feel confident using. The work of these experts includes: Implementing quality management systems Overseeing adherence to applicable laws Establishing regulatory strategies Quality and regulatory affairs experts accomplish these tasks through audits, inspections and risk assessments. Their expert work accelerates ideas to impact by creating streamlined quality assurance processes. Danaher offers quality and regulatory affairs jobs around the world. We operate in countries like India, the United States, Sweden, Singapore and Germany. Over 15 operating companies within Danaher offer plenty of opportunities for advancing careers while making a difference in the world. The positions we offer range from intern and entry-level to specialist and management roles. Change the World With Danaher A career in quality and regulatory affairs at Danaher means unlocking access to innovation. Our jobs in this field mean watching out for quality in the work we do and the products we create, leading to positive impacts around the globe. A career at Danaher also provides individual benefits, including: Competitive benefits that care for physical, financial and emotional needs Career development opportunities through the Danaher Business System (DBS) A workplace that fosters diversity, equity and inclusion Explore Our Regulatory Affairs and Quality Assurance Jobs Danaher is a world-leading innovator in science and technology. A job in regulatory affairs or quality assurance with us means advancing human health by meeting safety guidelines. Join our talent community to get tailored job recommendations based on your interests. Otherwise, view our open opportunities and apply for a chance to work together for a better tomorrow. #J-18808-Ljbffr
Regulatory Affairs Specialist
Posted 1 day ago
Job Viewed
Job Description
This Jobot Job is hosted by: Victoria Casal
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $37.5 - $48 per hour
A bit about us:
** THIS IS AN ONSITE POSITION IN VALENCIA (Occasionally in Burbank) **
Reputable Medical Device company
Why join us?
Competitive Salary
Employer paid Benefits (Medical/ Dental/ Vision)
PTO Package
Health Care and Dependent Care Flex Spending
401K
Profit-sharing program
Flexible work environment
Job Details
Responsibilities:
1. Develop and implement regulatory strategies and plans to ensure timely and successful market introduction of new products and updates to existing products.
2. Prepare and maintain technical files and design dossiers to support CE marking of products, including risk analysis and post-market surveillance reports.
3. Review and approve product labeling, promotional materials, and product changes as per regulatory requirements.
4. Ensure compliance with ISO 9001 and ISO 13485, MDR, EU MDD, MDD, CFR, and other relevant standards.
5. Maintain a robust document management system and ensure its compliance with regulatory requirements.
6. Liaise with regulatory authorities and notified bodies to resolve any issues that may arise during the product approval process.
7. Actively participate in internal and external audits and inspections.
8. Continuously monitor changes in the regulatory landscape and update the internal teams accordingly.
Qualifications:
1. A minimum of a Bachelor's degree in a scientific or technical field, or equivalent.
2. Minimum 4+ years of experience in regulatory affairs in the scientific industry.
3. Strong knowledge of QA, Quality Assurance, Quality Controls, ISO 9001, ISO13485, MDR, EU MDD, MDD, CFR, and Document Management.
4. Excellent written and verbal communication skills.
5. Strong analytical and problem-solving skills.
6. Ability to work collaboratively with cross-functional teams.
7. Strong attention to detail and the ability to manage multiple tasks simultaneously.
8. Proven track record of successful product approvals and audits.
9. Proficiency in using document management systems and other software tools.
You must be able to travel and work in Valencia with occasional visits to the Burbank facility.
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
Be The First To Know
About the latest Regulatory Jobs in United States !