Senior Director Regulatory Affairs Jobs in California
Senior Director Regulatory Affairs jobs in California represent one of the most active and competitive markets in the country, concentrated in life sciences, medical devices, and pharmaceuticals across the San Francisco Bay Area, San Diego, and Los Angeles. Major employers with deep California roots include Johnson & Johnson, Genentech, and Edwards Lifesciences, with openings at every level from regulatory manager to senior director. The most sought-after specialties are FDA submissions strategy, combination products, and biologics regulatory affairs. Find a role that fits below and apply directly.
Find JobsOverview
Showing 5 of 152+ Senior Director Regulatory Affairs 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+ Senior Director Regulatory Affairs Jobs in California
Find roles in California that match your experience and apply in just a few clicks.
Find JobsSenior Director Regulatory Affairs Jobs by City in California
Where California roles are concentrated, by current openings.
Senior Director Regulatory Affairs 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 senior director regulatory affairs jobs across California.
- Bachelor's or advanced degree in life sciences, pharmacy, chemistry, or a related field
- Minimum ten years of regulatory affairs experience in pharmaceuticals, biologics, or medical devices
- Demonstrated experience leading FDA submissions including NDAs, BLAs, PMAs, or 510(k)s
- Strong knowledge of applicable regulations including 21 CFR, ICH guidelines, and EU MDR
- Proven ability to lead and develop cross-functional regulatory teams in a matrix organization
- RAC certification from the Regulatory Affairs Professionals Society preferred by most California employers
Senior Director Regulatory Affairs Jobs in California: Frequently Asked Questions
How do you become a senior director regulatory affairs in California?
Reaching a senior director regulatory affairs role in California typically requires an advanced degree in a life sciences discipline combined with extensive experience in FDA-regulated industries. Most California employers expect deep expertise in a specific product category such as biologics, combination products, or Class III devices. Earning the Regulatory Affairs Certification from the Regulatory Affairs Professionals Society strengthens candidacy. California's dense cluster of biotech and medtech companies means progression often moves through mid-level regulatory manager and director roles at companies in the Bay Area or San Diego corridor.
How much do senior director regulatory affairses make in California?
Senior director regulatory affairses 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 senior director regulatory affairss in California?
Employers hiring senior director regulatory affairss in California right now include Revolution Medicines, Abbott, and Gilead Sciences, based on current listings on Migrate Mate as of September 2026. California's concentration of FDA-regulated life sciences companies means openings appear consistently across both established pharmaceutical manufacturers and fast-growing biotech and medical device firms headquartered in the state.
Which California cities have the most senior director regulatory affairs jobs?
The cities with the most senior director regulatory affairs openings in California are Redwood City, Irvine, and Alameda. The San Francisco Bay Area leads because of its massive biotech cluster anchored by companies like Genentech and Gilead, while San Diego's medtech and genomics sector drives strong demand there, and Los Angeles attracts openings from a broader mix of pharmaceutical and combination product companies.
Are there remote senior director regulatory affairs jobs in California?
Yes, and more than most fields, given that regulatory affairs work is largely documentation, strategy, and agency communication rather than hands-on lab or manufacturing work. About 40% of senior director regulatory affairs openings tied to California are remote or hybrid as of September 2026, reflecting the desk-based nature of the role. The functions most commonly performed remotely include submission writing, regulatory strategy development, and agency correspondence, while roles requiring close collaboration with clinical or manufacturing teams tend to require on-site presence.
How can I get hired as a senior director regulatory affairs in California with little or no experience?
The most realistic entry path is through a regulatory affairs associate or specialist role at a California-based biotech or medical device company, where you build direct FDA submission experience. Large California employers including Genentech, Abbott, and Intuitive Surgical run rotational programs and hire into junior regulatory roles that serve as the pipeline to senior leadership. Moving laterally from clinical affairs, quality assurance, or scientific affairs is a recognized route because those roles share regulatory touchpoints. Earning the Regulatory Affairs Certification early signals commitment and gives candidates from adjacent backgrounds a concrete credential edge.
Where can I find and apply to senior director regulatory affairs jobs in California?
You can find and apply to senior director regulatory affairs jobs in California on Migrate Mate, which lists current California openings for this role. Find the roles that fit your background and apply directly to the employers posting them.
See All 152+ Senior Director Regulatory Affairs Jobs in California
Find roles in California that match your experience and apply in just a few clicks.
Find Jobs