Senior Regulatory Affairs Specialist Jobs in California
Senior Regulatory Affairs Specialist jobs in California represent one of the most active markets in the country, concentrated in life sciences, medical devices, biotechnology, and pharmaceuticals, with demand from entry-level regulatory coordinators through principal specialists. The largest hiring metros are San Diego, the San Francisco Bay Area, and Los Angeles, where established employers like Johnson & Johnson, Abbott, and Genentech maintain significant regulatory operations. The most in-demand specializations include FDA submissions, 510(k) and PMA filings, and combination product regulation. Find a role that fits below and apply directly.
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Showing 5 of 7+ Senior Regulatory Affairs Specialist 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.
ABOUT ABBOTT
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
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.
ABOUT LINGO
Meet Lingo, a new biosensing technology that provides users a window into their body. Lingo tracks key biomarkers – such as glucose, ketones, and lactate – to help people make better decisions about their health and nutrition. Biowearable technology will digitize, decentralize and democratize healthcare, enabling consumers to take control of their own health.
THE OPPORTUNITY
Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare.
As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize products in the US. In this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. This is an exciting on-site opportunity at Lingo in Alameda, CA.
WHAT YOU’LL WORK ON
- Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices.
- Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance.
- Review and analyze labeling, advertising and promotional materials while working with Marketing teams to provide regulatory strategy and compliance input.
- Assist with promotional content development and review for compliance before distribution.
- Lead Regulatory Affairs Ad & Promo SOP development and review.
- Prepares robust regulatory applications/submissions to regulatory authorities.
- Assist in SOP development and review in support of "next-gen" product offerings.
- Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action.
- Utilize technical regulatory skills to propose strategies on complex issues.
- Ensure compliance with product post marketing requirements.
- Review product labeling to ensure compliance with relevant regulatory requirements.
- Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.
- Establishes and cultivates an extensive network of support to facilitate completion of assignments.
- Influences middle management on technical or business solutions.
REQUIRED QUALIFICATIONS:
- Bachelor's Degree; preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc.
- Minimum 2 yrs. regulatory experience and or 2 years relevant industrial experience typically with a quality; product-development/support; scientific affairs function.
PREFERRED QUALIFICATIONS:
- Advanced degree in Engineering, Sciences, or related discipline.
- Previous experience with 510(k)/PMA submissions or class I / II exempt software devices.
- Experience with software medical devices.
- 4-6 years’ experience in a regulated industry. Regulatory area is preferred but may consider quality assurance, software or systems research and development, or related area.
- Ability to work effectively on cross-functional teams.
- Must be able to juggle multiple and competing priorities.
- Ability to identify and solve problems and work independently with little oversight.
- Strong written, verbal, presentation, and organizational skills.
- Working knowledge of FDA QSR.
- Has a sound knowledge of a variety of alternatives and their impact on the business.
COMPENSATION
- The base pay for this position is $90,000.00 – $180,000.00. In specific locations, the pay range may vary from the range posted.
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.
ABOUT ABBOTT
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
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.
ABOUT LINGO
Meet Lingo, a new biosensing technology that provides users a window into their body. Lingo tracks key biomarkers – such as glucose, ketones, and lactate – to help people make better decisions about their health and nutrition. Biowearable technology will digitize, decentralize and democratize healthcare, enabling consumers to take control of their own health.
THE OPPORTUNITY
Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare.
As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize products in the US. In this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. This is an exciting on-site opportunity at Lingo in Alameda, CA.
WHAT YOU’LL WORK ON
- Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices.
- Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance.
- Review and analyze labeling, advertising and promotional materials while working with Marketing teams to provide regulatory strategy and compliance input.
- Assist with promotional content development and review for compliance before distribution.
- Lead Regulatory Affairs Ad & Promo SOP development and review.
- Prepares robust regulatory applications/submissions to regulatory authorities.
- Assist in SOP development and review in support of "next-gen" product offerings.
- Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action.
- Utilize technical regulatory skills to propose strategies on complex issues.
- Ensure compliance with product post marketing requirements.
- Review product labeling to ensure compliance with relevant regulatory requirements.
- Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.
- Establishes and cultivates an extensive network of support to facilitate completion of assignments.
- Influences middle management on technical or business solutions.
REQUIRED QUALIFICATIONS:
- Bachelor's Degree; preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc.
- Minimum 2 yrs. regulatory experience and or 2 years relevant industrial experience typically with a quality; product-development/support; scientific affairs function.
PREFERRED QUALIFICATIONS:
- Advanced degree in Engineering, Sciences, or related discipline.
- Previous experience with 510(k)/PMA submissions or class I / II exempt software devices.
- Experience with software medical devices.
- 4-6 years’ experience in a regulated industry. Regulatory area is preferred but may consider quality assurance, software or systems research and development, or related area.
- Ability to work effectively on cross-functional teams.
- Must be able to juggle multiple and competing priorities.
- Ability to identify and solve problems and work independently with little oversight.
- Strong written, verbal, presentation, and organizational skills.
- Working knowledge of FDA QSR.
- Has a sound knowledge of a variety of alternatives and their impact on the business.
COMPENSATION
- The base pay for this position is $90,000.00 – $180,000.00. In specific locations, the pay range may vary from the range posted.
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 7 Senior Regulatory Affairs Specialist Jobs in California
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Find JobsSenior Regulatory Affairs Specialist Jobs by City in California
Where California roles are concentrated, by current openings.
Senior Regulatory Affairs Specialist Job Market in California
A snapshot from current California openings, updated as new roles post.
Who's Hiring
- Abbott2
- Amazon1
- Evalve1
- Intuitive (Intuitive Surgical)1
- LGM Pharma1
Top Industries Hiring
- Biotechnology & Pharmaceuticals4
- Medical Devices2
- Healthcare & Medical Services1
- Technology & Software1
What California Employers Look For
The qualifications that appear most often in senior regulatory affairs specialist jobs across California.
- Bachelor's degree in life sciences, engineering, chemistry, or a related field required
- Five or more years of regulatory affairs experience in medical devices or pharmaceuticals
- Direct experience with FDA submissions including 510(k), PMA, or BLA filings
- Familiarity with California-based manufacturing site compliance and state CDPH requirements
- Proficiency with regulatory information management systems such as Veeva Vault
- Strong cross-functional collaboration skills with R&D, quality, and clinical teams
Senior Regulatory Affairs Specialist Jobs in California: Frequently Asked Questions
How do you become a senior regulatory affairs specialist in California?
Most senior regulatory affairs specialists in California start with a bachelor's degree in a life science, engineering, or health-related field, then build experience in regulatory coordination or quality assurance roles within the state's dense biotech or medical device sector. California does not issue a state license for regulatory affairs, but the Regulatory Affairs Professionals Society offers the RAC credential, which California employers in the FDA-regulated device and pharma space consistently recognize as a mark of professional competency.
How much do senior regulatory affairs specialists make in California?
Senior regulatory affairs specialists 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 regulatory affairs specialists in California?
Employers hiring senior regulatory affairs specialists in California right now include Abbott, Amazon, and Evalve, based on current listings on Migrate Mate as of June 2026. California's dense concentration of FDA-regulated medical device and biopharmaceutical companies means regulatory talent is in consistent demand across both large multinationals and well-funded emerging companies.
Which California cities have the most senior regulatory affairs specialist jobs?
The cities with the most senior regulatory affairs specialist openings in California are Sunnyvale, Alameda, and Irvine. San Diego and the Bay Area lead because they anchor California's two largest life sciences and biotech clusters, while Los Angeles draws openings from a mix of diagnostics, combination products, and pharmaceutical companies that have established regulatory functions there.
Are there remote senior regulatory affairs specialist jobs in California?
Yes, and more than many comparable roles, since regulatory work is primarily document-driven and does not require physical lab or manufacturing presence. About 0% of senior regulatory affairs specialist openings tied to California are remote or hybrid as of June 2026, reflecting broader flexibility in this function. Submissions management, regulatory strategy, and labeling review are the sub-areas most consistently offered as fully remote.
How can I get hired as a senior regulatory affairs specialist in California with little or no experience?
The most realistic entry path is moving into a regulatory affairs coordinator or quality assurance associate role at a California medical device or biotech company, where hands-on exposure to FDA filings begins immediately. Large California employers like Becton Dickinson and Align Technology hire quality and regulatory associates who grow into specialist roles internally. Pursuing the RAC credential while in an adjacent role, such as clinical operations, quality control, or technical writing, meaningfully accelerates the transition for candidates without direct submissions experience.
Where can I find and apply to senior regulatory affairs specialist jobs in California?
You can find and apply to senior regulatory affairs specialist jobs in California on Migrate Mate, which lists current California openings from employers actively hiring for this role. Find roles that fit your background and apply directly from each listing.
See All 7 Senior Regulatory Affairs Specialist Jobs in California
Find roles in California that match your experience and apply in just a few clicks.
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