Regulatory Affairs Analyst Jobs in California
Regulatory affairs analyst jobs in California are among the most active in the country, concentrated in life sciences, medical devices, biotechnology, and pharmaceutical manufacturing across the San Diego, San Francisco Bay Area, and Los Angeles metros. Major employers with deep California roots include Johnson & Johnson, Genentech, and Edwards Lifesciences, which hire across seniority levels from entry-level associates to senior regulatory strategists. The most in-demand specialties are FDA submissions, quality systems compliance, and combination product regulation. Scan the live roles below and apply to whichever ones fit.
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Showing 5 of 147+ Regulatory Affairs Analyst jobs
INTRODUCTION
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 115,000 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.
At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
THE OPPORTUNITY
The Principal RA Specialist will work on-site out of our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
This is an exciting opportunity with responsibilities for leading global regulatory submissions, which include but not limited to premarket submissions, pre-submissions and clinical trial applications, which include medical hardware and digital health technology solutions to address the spectrum of customer needs.
This individual has department level influence with experience in US/EU/global submissions and on-market changes and is generally recognized as an expert resource both within Abbott and externally. The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy, and provide executive management with regulatory metrics/information.
WHAT YOU’LL WORK ON
- Develop global regulatory strategies for product development and planning throughout the product lifecycle.
- Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
- Provide technical leadership and strategic input on complex issues and to business units.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
- Create project plans and timelines.
- Lead functional groups in the development of relevant data to complete a regulatory submission.
- Write and edit technical documents.
- Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions.
- Negotiate with regulatory authorities during the development and review process to ensure submission approval.
- Review and approve labeling to ensure compliance.
- Monitor emerging issues and identify solutions.
- Negotiate internally and externally with regulatory agencies.
- Evaluate regulatory risks of corporate policies.
- Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
- Ensure compliance with product post-marketing approval requirements.
- Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events.
- Actively contribute to the development and functioning of the crisis/issue management program.
- Analyze product-associated problems and develop proposals for solutions.
- Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies.
- Provide regulatory input for product recalls and recall communications.
REQUIRED QUALIFICATIONS
- Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications).
- Experienced in regulatory submissions for In Vitro Diagnostic Devices and/or Medical Devices.
- Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Device Regulation (2017/745) and/or the In Vitro Diagnostic Regulation (IVDR 2017/746).
PREFERRED QUALIFICATIONS
- 5 years’ experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus.
- Experience with either 510(k) applications, PMA supplements, US Device Regulations, or with EU and other International Medical Device Regulations and Submissions.
- Familiar with relevant regulatory requirements for medical devices including Quality Systems standards, clinical investigations, ICH guidelines.
- Experience with word processing, spreadsheet and presentation graphic software packages.
- Experience working in a broader enterprise/cross-division business unit model.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Ability to identify, solve problems, and work independently with little oversight.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes, and meets deadlines in a timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to travel approximately 5%, including international travel.
COMPENSATION
- The base pay for this position is $100,000.00 – $200,000.00. In specific locations, the pay range may vary from the range posted.
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.
INTRODUCTION
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 115,000 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.
At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
THE OPPORTUNITY
The Principal RA Specialist will work on-site out of our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
This is an exciting opportunity with responsibilities for leading global regulatory submissions, which include but not limited to premarket submissions, pre-submissions and clinical trial applications, which include medical hardware and digital health technology solutions to address the spectrum of customer needs.
This individual has department level influence with experience in US/EU/global submissions and on-market changes and is generally recognized as an expert resource both within Abbott and externally. The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy, and provide executive management with regulatory metrics/information.
WHAT YOU’LL WORK ON
- Develop global regulatory strategies for product development and planning throughout the product lifecycle.
- Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
- Provide technical leadership and strategic input on complex issues and to business units.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
- Create project plans and timelines.
- Lead functional groups in the development of relevant data to complete a regulatory submission.
- Write and edit technical documents.
- Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions.
- Negotiate with regulatory authorities during the development and review process to ensure submission approval.
- Review and approve labeling to ensure compliance.
- Monitor emerging issues and identify solutions.
- Negotiate internally and externally with regulatory agencies.
- Evaluate regulatory risks of corporate policies.
- Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
- Ensure compliance with product post-marketing approval requirements.
- Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events.
- Actively contribute to the development and functioning of the crisis/issue management program.
- Analyze product-associated problems and develop proposals for solutions.
- Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies.
- Provide regulatory input for product recalls and recall communications.
REQUIRED QUALIFICATIONS
- Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications).
- Experienced in regulatory submissions for In Vitro Diagnostic Devices and/or Medical Devices.
- Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Device Regulation (2017/745) and/or the In Vitro Diagnostic Regulation (IVDR 2017/746).
PREFERRED QUALIFICATIONS
- 5 years’ experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus.
- Experience with either 510(k) applications, PMA supplements, US Device Regulations, or with EU and other International Medical Device Regulations and Submissions.
- Familiar with relevant regulatory requirements for medical devices including Quality Systems standards, clinical investigations, ICH guidelines.
- Experience with word processing, spreadsheet and presentation graphic software packages.
- Experience working in a broader enterprise/cross-division business unit model.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Ability to identify, solve problems, and work independently with little oversight.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes, and meets deadlines in a timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to travel approximately 5%, including international travel.
COMPENSATION
- The base pay for this position is $100,000.00 – $200,000.00. In specific locations, the pay range may vary from the range posted.
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.
See All 147+ Regulatory Affairs Analyst Jobs in California
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Find JobsRegulatory Affairs Analyst Jobs by City in California
Where California roles are concentrated, by current openings.
Regulatory Affairs Analyst Job Market in California
A snapshot from current California openings, updated as new roles post.
Who's Hiring
- Revolution Medicines20
- Abbott9
- Evalve4
- Gilead Sciences4
- Procept BioRobotics4
Top Industries Hiring
- Biotechnology & Pharmaceuticals51
- Medical Devices8
- Retail3
- Technology & Software3
- Education2
What California Employers Look For
The qualifications that appear most often in regulatory affairs analyst jobs across California.
- Bachelor's degree in life sciences, chemistry, engineering, or a related field required
- Experience preparing and submitting FDA regulatory submissions such as 510k or BLA
- Knowledge of FDA regulations, ICH guidelines, and applicable CFR requirements
- Familiarity with California-based medical device or pharmaceutical manufacturing environments
- Strong technical writing skills for regulatory documents, dossiers, and correspondence
- Regulatory Affairs Certification (RAC) from RAPS preferred for mid-level and senior roles
Regulatory Affairs Analyst Jobs in California: Frequently Asked Questions
How do you become a regulatory affairs analyst in California?
The most direct path is a bachelor's degree in a life sciences or engineering discipline, followed by entry-level work in quality assurance, clinical operations, or manufacturing at a California biotech or medical device company. California has no state-issued license specific to regulatory affairs, but the Regulatory Affairs Certification from RAPS is widely recognized by California employers and strengthens candidates for roles requiring FDA submission experience. Graduate programs in regulatory science at California universities provide a faster route into senior positions.
Which companies hire regulatory affairs analysts in California?
California regulatory affairs analyst roles are posted by Revolution Medicines, Abbott, and Evalve and others right now, based on current listings on Migrate Mate as of July 2026. California's concentration of FDA-regulated life sciences employers means openings appear across large pharmaceutical manufacturers, medical device companies, and early-stage biotechs, particularly in the Bay Area and San Diego corridors.
Which California cities have the most regulatory affairs analyst jobs?
Redwood City, Alameda, and San Diego account for the largest share of regulatory affairs analyst openings in California. The Bay Area's density of established biotech and pharmaceutical headquarters drives volume in that region, while San Diego's large medical device and genomics cluster and Los Angeles's growing biopharma presence sustain consistent openings outside the Bay Area.
Are there remote regulatory affairs analyst jobs in California?
Yes, and more than most fields. About 27% of regulatory affairs analyst openings tied to California are remote or hybrid as of July 2026, reflecting how much of the work centers on document preparation, regulatory strategy, and agency correspondence rather than on-site lab activity. The portions of the role most commonly performed remotely include submission writing, gap analysis, and regulatory intelligence research.
How can I get hired as a regulatory affairs analyst in California with little or no experience?
The most realistic entry point is a quality assurance associate or regulatory coordinator role at a California medical device or biotech company, which provides direct exposure to FDA documentation and audit readiness. Large California employers including Baxter, Hologic, and Gilead Sciences run structured rotational or associate programs that place new graduates into regulatory-adjacent functions. Earning the RAPS Regulatory Affairs Certification early and building a portfolio of mock submissions or SOPs through university regulatory science coursework gives candidates a concrete edge when applying to these programs.
Where can I find and apply to regulatory affairs analyst jobs in California?
You can find and apply to regulatory affairs analyst jobs in California on Migrate Mate, which lists current California openings. Search the available roles, identify the ones that fit your background and location, and apply directly to the positions that match.
See All 147+ Regulatory Affairs Analyst Jobs in California
Find roles in California that match your experience and apply in just a few clicks.
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