Regulatory Affairs Director Jobs in California
Regulatory Affairs Director jobs in California are among the most active in the country, concentrated in the life sciences, biotechnology, and medical device sectors that anchor the state's economy at every seniority level from newly promoted manager to global regulatory head. The largest hiring volumes are in the San Francisco Bay Area, San Diego, and Los Angeles, where employers such as Genentech, Edwards Lifesciences, and Hologic maintain deep regulatory functions. Demand is strongest in professionals with expertise in FDA submissions, combination products, and international regulatory strategy, particularly for Class II and Class III medical devices and biologics. Find a role that fits below and apply directly.
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Showing 5 of 152+ Regulatory Affairs Director 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.
See All 152+ Regulatory Affairs Director Jobs in California
Find roles in California that match your experience and apply in just a few clicks.
Find JobsRegulatory Affairs Director Jobs by City in California
Where California roles are concentrated, by current openings.
Regulatory Affairs Director Job Market in California
A snapshot from current California openings, updated as new roles post.
Who's Hiring
- Revolution Medicines17
- Abbott12
- Gilead Sciences9
- JenaValve Technology4
- Intuitive (Intuitive Surgical)4
Top Industries Hiring
- Biotechnology & Pharmaceuticals34
- Medical Devices6
- Retail2
- Technology & Software2
- Healthcare & Medical Services2
What California Employers Look For
The qualifications that appear most often in regulatory affairs director jobs across California.
- Bachelor's or advanced degree in life sciences, engineering, or a related scientific field
- Minimum of seven to ten years of regulatory affairs experience in pharma, biotech, or medical devices
- Demonstrated experience leading FDA submissions including 510(k), PMA, BLA, or NDA filings
- Working knowledge of California Department of Public Health manufacturing and quality regulations
- RAC credential from the Regulatory Affairs Professionals Society strongly preferred by California employers
- Experience managing cross-functional teams and external regulatory consultants or contract research organizations
Regulatory Affairs Director Jobs in California: Frequently Asked Questions
How do you become a regulatory affairs director in California?
Most regulatory affairs directors in California reach the role through a combination of a life sciences degree and progressively senior positions in regulatory submissions, quality assurance, or clinical affairs at a biotech or medical device company. The Regulatory Affairs Professionals Society's RAC credential is widely recognized by California employers and signals formal competency. California does not issue a state-specific license for regulatory affairs, but familiarity with California Department of Public Health manufacturing requirements is a practical asset for senior candidates.
How much do regulatory affairs directors make in California?
Regulatory affairs directors in California earn a median of about $96,980 a year, based on May 2025 Bureau of Labor Statistics wage data, ranging from around $57,530 for the lowest 10% to over $158,280 for the top 10%. Pay rises with experience, specialty, and employer.
Which companies hire regulatory affairs directors in California?
Employers hiring regulatory affairs directors in California right now include Revolution Medicines, Abbott, and Gilead Sciences, based on current listings on Migrate Mate as of September 2026. California's dense concentration of biotech, pharmaceutical, and medical device headquarters means hiring is consistent year-round, with particularly high volume in the Bay Area and San Diego corridors.
Which California cities have the most regulatory affairs director jobs?
Redwood City, Irvine, and Alameda have the most regulatory affairs director openings in California. The Bay Area leads because of its concentration of biopharmaceutical and biotech headquarters, San Diego is driven by its medical device and genomics cluster, and Los Angeles draws demand from pharmaceutical manufacturers and combination product companies with large West Coast operations.
Are there remote regulatory affairs director jobs in California?
Yes, and more than most fields. About 40% of regulatory affairs director openings tied to California are remote or hybrid as of September 2026, reflecting the desk-based and document-intensive nature of much regulatory work. Roles centered on strategy, submissions writing, and agency correspondence tend to be the most flexible, while positions requiring hands-on review of manufacturing facilities or laboratory audits typically require on-site presence.
How can I get hired as a regulatory affairs director in California with little or no experience?
The most realistic entry path is moving into a regulatory affairs specialist or associate role from an adjacent position such as quality assurance, clinical research coordination, or scientific writing at a California biotech or medical device company. Larger employers such as those in the Bay Area and San Diego biotech clusters regularly hire associate regulatory affairs professionals who want to build toward director-level roles. Earning the RAC Foundation credential and building a portfolio of submission-support experience on even one FDA filing meaningfully strengthens a candidate's profile early in their career.
Where can I find and apply to regulatory affairs director jobs in California?
You can find and apply to regulatory affairs director jobs in California on Migrate Mate, which lists current California openings across biotech, pharma, and medical device employers. Find roles that fit your experience and apply directly to each listing.
See All 152+ Regulatory Affairs Director Jobs in California
Find roles in California that match your experience and apply in just a few clicks.
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