Regulatory Affairs Lead Jobs
Regulatory Affairs Lead jobs are open across pharmaceuticals, medical devices, biotechnology, and consumer products, from senior specialist to director level, with specializations in drug approval, quality systems, and labeling compliance. Find a role that fits from the openings below and apply directly.
Find Regulatory Affairs Lead JobsLooking for remote work? View remote regulatory affairs lead jobs →Overview
Showing 5 of 616+ Regulatory Affairs Lead jobs
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
The Opportunity
Abbott is seeking a highly motivated and experienced Principal Regulatory Affairs Specialist to join our Vascular Division team on-site in Santa Clara, CA or Temecula, CA. In this role, you will provide regulatory leadership for a portfolio of endovascular medical devices used in the treatment of peripheral artery disease and support global regulatory strategies throughout the product lifecycle. The Principal Regulatory Affairs Specialist will manage complex regulatory activities, including on-market product support, product development projects, lifecycle management initiatives, regulatory assessments, and global submissions. This individual will serve as a key regulatory partner to cross-functional teams and contribute to strategic decision-making by interpreting regulatory requirements, evaluating business risks, and developing practical regulatory solutions. The candidate will have demonstrated experience preparing and executing regulatory strategies, supporting interactions with regulatory authorities and notified bodies, and successfully obtaining regulatory approvals for medical devices in the U.S., E.U. and other international markets.
What You’ll Work On
- Develop and execute global regulatory strategies to support product changes, manufacturing transfers, lifecycle management activities, new product development, and business objectives.
- Independently prepare regulatory submissions and documentation for medical devices.
- Lead regulatory assessments for design, manufacturing, supplier, labeling, and process changes to determine global regulatory requirements and submission strategies.
- Review and approve engineering change orders, protocols, reports, specifications, risk management documentation, validation documents, and other project-related records.
- Support and maintain U.S. and international product registrations, licenses, approvals, and technical documentation throughout the product lifecycle.
- Serve as the regulatory lead on cross-functional project teams, providing strategic guidance throughout product development and commercialization activities.
- Interpret and apply global regulatory requirements, standards, guidance documents, and industry best practices to support business needs.
- Prepare and maintain FDA submissions, including 510(k)s, PMAs, PMA supplements, and other required submissions, as applicable.
- Support EU MDR regulatory activities, including Technical Documentation updates, change assessments, and notified body interactions.
- Collaborate with Regulatory Operations, Quality, Clinical, R&D, Manufacturing, Supply Chain, Marketing, and other functional groups to ensure timely execution of regulatory deliverables.
- Analyze evolving regulatory requirements and provide recommendations regarding business impact, compliance risks, and implementation plans.
- Support regulatory authority and notified body inspections, audits, inquiries, and responses.
- Support all company initiatives in accordance with Quality Management Systems (QMS), Environmental Management Systems (EMS), and applicable regulatory requirements.
- Maintain compliance with FDA regulations, international regulations, company policies, procedures, and quality requirements.
- Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Act as liaison between the Company and the various regulatory agencies. Interfaces directly with FDA and Notified Bodies.
- May manage direct reports or serve as mentor to other regulatory affairs specialists
- Perform other duties and responsibilities as assigned.
Required Qualifications
- Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
- Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices.
- Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
Preferred Qualifications
- 6-8 years experience in medical device industry with experience working with Class II and/or Class III devices.
- Regulatory affairs professional experience supporting medical devices.
- Experience leading regulatory activities for cardiovascular, endovascular, peripheral vascular, implantable, catheter-based, or other complex medical device technologies.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
- Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
- Has a strong attention-to-detail
- Strong written, verbal, presentation, and organizational skills as well as analytical and problem-solving skills.
- Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.
- Experience authoring and submitting Traditional, Special, or Abbreviated 510(k)s; PMAs; PMA supplements; IDEs; or other FDA submissions.
- Experience supporting EU MDR (2017/745) Technical Documentation, change notifications, clinical evaluation documentation, or notified body interactions.
- Knowledge of global regulatory requirements and submission pathways outside the United States and European Union; in particular highly regulated countries such as China, Canada, Australia, or Brazil.
- Experience participating in regulatory authority inspections, notified body audits, and responses to regulatory inquiries.
- Experience reviewing risk-based regulatory assessments and supporting product risk management activities in accordance with ISO 14971.
- Experience reviewing clinical data.
- Experience with electronic document management systems (EDMS), product lifecycle management (PLM) systems, eQMS platforms, and change control processes.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work effectively within a team and as an individual contributor in a fast-paced, changing environment.
- Experience managing direct reports or dotted line manager to regulatory affairs specialists
- Ability to leverage, manage and/or engage others to accomplish projects.
- Applies critical thinking to multitask, prioritize and meet deadlines in a timely manner.
- Ability to identify risk areas and escalate issues as appropriate.
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
The Opportunity
Abbott is seeking a highly motivated and experienced Principal Regulatory Affairs Specialist to join our Vascular Division team on-site in Santa Clara, CA or Temecula, CA. In this role, you will provide regulatory leadership for a portfolio of endovascular medical devices used in the treatment of peripheral artery disease and support global regulatory strategies throughout the product lifecycle. The Principal Regulatory Affairs Specialist will manage complex regulatory activities, including on-market product support, product development projects, lifecycle management initiatives, regulatory assessments, and global submissions. This individual will serve as a key regulatory partner to cross-functional teams and contribute to strategic decision-making by interpreting regulatory requirements, evaluating business risks, and developing practical regulatory solutions. The candidate will have demonstrated experience preparing and executing regulatory strategies, supporting interactions with regulatory authorities and notified bodies, and successfully obtaining regulatory approvals for medical devices in the U.S., E.U. and other international markets.
What You’ll Work On
- Develop and execute global regulatory strategies to support product changes, manufacturing transfers, lifecycle management activities, new product development, and business objectives.
- Independently prepare regulatory submissions and documentation for medical devices.
- Lead regulatory assessments for design, manufacturing, supplier, labeling, and process changes to determine global regulatory requirements and submission strategies.
- Review and approve engineering change orders, protocols, reports, specifications, risk management documentation, validation documents, and other project-related records.
- Support and maintain U.S. and international product registrations, licenses, approvals, and technical documentation throughout the product lifecycle.
- Serve as the regulatory lead on cross-functional project teams, providing strategic guidance throughout product development and commercialization activities.
- Interpret and apply global regulatory requirements, standards, guidance documents, and industry best practices to support business needs.
- Prepare and maintain FDA submissions, including 510(k)s, PMAs, PMA supplements, and other required submissions, as applicable.
- Support EU MDR regulatory activities, including Technical Documentation updates, change assessments, and notified body interactions.
- Collaborate with Regulatory Operations, Quality, Clinical, R&D, Manufacturing, Supply Chain, Marketing, and other functional groups to ensure timely execution of regulatory deliverables.
- Analyze evolving regulatory requirements and provide recommendations regarding business impact, compliance risks, and implementation plans.
- Support regulatory authority and notified body inspections, audits, inquiries, and responses.
- Support all company initiatives in accordance with Quality Management Systems (QMS), Environmental Management Systems (EMS), and applicable regulatory requirements.
- Maintain compliance with FDA regulations, international regulations, company policies, procedures, and quality requirements.
- Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Act as liaison between the Company and the various regulatory agencies. Interfaces directly with FDA and Notified Bodies.
- May manage direct reports or serve as mentor to other regulatory affairs specialists
- Perform other duties and responsibilities as assigned.
Required Qualifications
- Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
- Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices.
- Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
Preferred Qualifications
- 6-8 years experience in medical device industry with experience working with Class II and/or Class III devices.
- Regulatory affairs professional experience supporting medical devices.
- Experience leading regulatory activities for cardiovascular, endovascular, peripheral vascular, implantable, catheter-based, or other complex medical device technologies.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
- Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
- Has a strong attention-to-detail
- Strong written, verbal, presentation, and organizational skills as well as analytical and problem-solving skills.
- Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.
- Experience authoring and submitting Traditional, Special, or Abbreviated 510(k)s; PMAs; PMA supplements; IDEs; or other FDA submissions.
- Experience supporting EU MDR (2017/745) Technical Documentation, change notifications, clinical evaluation documentation, or notified body interactions.
- Knowledge of global regulatory requirements and submission pathways outside the United States and European Union; in particular highly regulated countries such as China, Canada, Australia, or Brazil.
- Experience participating in regulatory authority inspections, notified body audits, and responses to regulatory inquiries.
- Experience reviewing risk-based regulatory assessments and supporting product risk management activities in accordance with ISO 14971.
- Experience reviewing clinical data.
- Experience with electronic document management systems (EDMS), product lifecycle management (PLM) systems, eQMS platforms, and change control processes.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work effectively within a team and as an individual contributor in a fast-paced, changing environment.
- Experience managing direct reports or dotted line manager to regulatory affairs specialists
- Ability to leverage, manage and/or engage others to accomplish projects.
- Applies critical thinking to multitask, prioritize and meet deadlines in a timely manner.
- Ability to identify risk areas and escalate issues as appropriate.
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.
Regulatory Affairs Lead Jobs by Experience Level
See All 616+ Regulatory Affairs Lead Jobs
Find roles that match your experience and apply in just a few clicks.
Find Regulatory Affairs Lead JobsRegulatory Affairs Lead Job Market
Who's Hiring
- Revolution Medicines18
- Abbott16
- Gilead Sciences9
- Stryker8
- Boehringer Ingelheim7
Top Industries Hiring
- Biotechnology & Pharmaceuticals74
- Healthcare & Medical Services15
- Medical Devices14
- Consulting & Professional Services8
- Distribution & Wholesale6
What Employers Look For
The qualifications that appear most often in regulatory affairs lead jobs.
- Bachelor's degree or higher in life sciences, pharmacy, chemistry, or a related field
- Five or more years of experience managing regulatory submissions to FDA or comparable agencies
- Hands-on experience authoring or coordinating IND, NDA, BLA, 510(k), or PMA submissions
- Proficiency with electronic submission systems such as eCTD publishing tools or Veeva Vault RIM
- Regulatory Affairs Certification (RAC) from RAPS preferred or required by many employers
- Strong cross-functional communication skills for working with clinical, quality, and legal teams
Tips for Your Regulatory Affairs Lead Job Search
Tailor your resume to submission types
Hiring managers scan for the specific submission formats you've owned, whether IND, NDA, 510(k), or CE marking. Name each type directly in your experience bullets rather than describing your regulatory work in general terms.
List your therapeutic area expertise upfront
Oncology, rare disease, and combination products each carry different regulatory pathways. Calling out your therapeutic area in your resume summary gets you past filters that sort by product type before a recruiter ever reads further.
Apply early to roles that fit
Migrate Mate lists regulatory affairs lead openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Target roles by agency relationship experience
Postings that specify FDA, EMA, or Health Canada experience are filtering hard on that credential. If you've managed a Type B or C meeting, a CAT interaction, or a pre-submission, name those interactions explicitly so your application clears the first cut.
Prepare a case study for your interview
Most regulatory affairs lead interviews include a scenario question about a deficiency letter, a labeling dispute, or a timeline crunch. Walking through a real submission challenge you navigated, including the agency feedback and how you resolved it, is far more persuasive than describing your process in the abstract.
Negotiate using scope, not just salary
In regulatory affairs, the portfolio size, number of direct reports, and budget authority you hold at offer stage shape your next move. Confirm those terms in writing before you sign, because scope determines your leverage for the role after this one.
Regulatory Affairs Lead Jobs: Frequently Asked Questions
Which companies are hiring the most regulatory affairs leads?
The companies hiring the most regulatory affairs leads right now include Revolution Medicines, Abbott, and Gilead Sciences, with the largest share of openings in California, Massachusetts, and New Jersey, based on current listings on Migrate Mate as of September 2026. Demand is concentrated at mid-size and large pharmaceutical, medical device, and contract research organizations actively managing product pipelines.
How many regulatory affairs lead jobs are remote?
About 63% of regulatory affairs lead openings are fully remote or hybrid as of September 2026, reflecting the document-heavy, cross-functional nature of much of the work. Roles focused on submissions strategy, labeling, and post-market surveillance tend to be the most remote-friendly, while positions requiring direct lab interaction or on-site agency liaison work are more likely to require in-person presence.
How do you become a regulatory affairs lead?
Most regulatory affairs leads start in a specialist or associate role after earning a degree in a life science field, then build experience across at least one full product lifecycle, from preclinical through approval. Earning the RAC credential from RAPS strengthens your candidacy for lead-level roles. Moving into a lead position typically requires owning a submission end-to-end, managing timelines independently, and demonstrating you can coordinate across clinical, quality, and legal functions without constant oversight.
Can you get hired as a regulatory affairs lead with limited experience?
Breaking into a lead-level role with limited experience is possible if you can show depth in a specific submission type or therapeutic area rather than breadth. Candidates who have owned a single submission from start to approval, even in a supporting role, are more competitive than those with broad but shallow exposure. Contract or consulting work at a CRO can accelerate the timeline because it compresses experience across multiple clients and product types into a shorter period.
What does the regulatory affairs lead interview process look like?
Most regulatory affairs lead interviews run three to four rounds. The first is a recruiter screen focused on submission experience and agency familiarity. A hiring manager interview follows, covering your approach to cross-functional coordination and how you handle agency feedback. Later rounds often include a technical exercise, such as reviewing a mock deficiency letter or walking through a submission strategy, and a panel conversation with quality, clinical, or legal stakeholders who will work directly with you.
Where can I find and apply to regulatory affairs lead jobs?
You can find and apply to regulatory affairs lead jobs on Migrate Mate, which lists current openings from companies across the United States. Search the listings to find roles that match your submission experience, therapeutic area, and preferred location or remote arrangement, then apply directly to each listing that fits.
See All 616+ Regulatory Affairs Lead Jobs
Find roles that match your experience and apply in just a few clicks.
Find Regulatory Affairs Lead Jobs