Regulatory Affairs Specialist Jobs in California
Regulatory Affairs Specialist jobs in California are among the most active in the country, concentrated in life sciences, medical devices, biotechnology, and pharmaceuticals across a seniority range from entry-level regulatory associate through senior principal. The largest hiring metros are San Diego, San Francisco Bay Area, and Los Angeles, where companies like Thermo Fisher Scientific, Gilead Sciences, and Johnson and Johnson maintain significant California operations. Demand is strongest for specialists with expertise in FDA submissions, 510(k) pathways, and combination product regulations. Find a role that fits below and apply directly.
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Showing 5 of 19+ Regulatory Affairs Specialist jobs
DESCRIPTION
Amazon Devices and Services is an innovative research and development company that designs and engineers high-profile consumer electronics. We are known for creating the Kindle family of products, and devices like Fire tablets, Fire TV and Echo Frames. Working as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in class products.
The ideal candidate will have experience building a regulatory strategy and supporting documents from scratch, including developing, leading, and driving proactive execution of a global regulatory strategy. They must enjoy problem solving and possess practical hands-on knowledge of FDA submissions and reporting requirements across the product lifecycle for medical products.
ROLE AND RESPONSIBILITIES
- Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements.
- Develops global regulatory strategies for new and modified products.
- Prepares and submits regulatory submissions to health agencies.
- Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures.
- Provides regulatory assessment for manufacturing, design changes and product risk assessment.
- Reviews and advises on labeling, product claims, marketing brochures, advertising and promotional material and other publications to ensure compliance with regulations.
- Plans, schedules, and arranges all activities to support regulatory timelines.
- Partners with quality system leadership to maintain regulatory and quality compliance requirements, including support during regulatory audits.
- Maintains annual licenses, registrations, and listing information. Assists with compliance to product post-marketing approval requirements.
- Supports the product release process.
- Acts as an SME for internal and external audits and inspections by internal teams or external regulatory authorities.
- Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, company policies, and governing procedures and processes.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Reviews protocols and reports to support regulatory submissions.
- Creates, reviews and approves engineering change requests.
- Acts as liaison between the Company and the various regulatory agencies. Interfaces directly with FDA and Notified Bodies.
- Provide interpretation of regulatory authorities’ feedback, policies and guidelines.
- Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills as evidenced by past performance on drug development project teams.
ABOUT THE TEAM
The Quality & Lean, Medical Devices Operational Compliance Center (MD-OCC), consists of business process analysts, quality system experts, program managers, supply chain experts, regulatory experts, clinical affairs, and internal auditors. Our mission is to establish and manage Amazon Devices and Services Medical Product Quality and Regulatory Systems; enabling the manufacture and distribution of safe, effective and high-quality medical products for at home, mobile health and wellness customers.
BASIC QUALIFICATIONS
- 7+ years of working directly with engineering teams experience
- 5+ years of technical product or program management experience
- 5+ years of technical program management working directly with software engineering teams experience
- Experience managing programs across cross functional teams, building processes and coordinating release schedules
- Experience with regulatory filings and reports or equivalent
- Experience that includes strong analytical skills, attention to detail, and effective communication abilities, or experience working with customers with a passion for delivering exceptional service
- Experience working on multi-team, cross-disciplinary projects
- Experience that includes strong analytical skills, attention to detail, and effective communication abilities
- Experience in identifying incomplete or inaccurate data, identifying the root cause and creating/implementing an escalation plan, or experience communicating results to senior leadership
- Bachelor’s Degree in Scientific discipline e.g. Biomedical Engineering, life Sciences, Biology (or equivalent qualifications)
- 5 years of experience working within the requirements of 21 CFR 820, ISO13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
- 5 years of experience in a regulated industry with experience working with Class II and/or Class III devices.
- Knowledge and understanding of guiding principles in device development such as benefit/risk profile, statistical design or drug dose selection
- Experience with medical device software requirements.
PREFERRED QUALIFICATIONS
- 5+ years of project management disciplines including scope, schedule, budget, quality, along with risk and critical path management experience
- Experience managing projects across cross functional teams, building sustainable processes and coordinating release schedules
- Experience defining KPI's/SLA's used to drive multi-million dollar businesses and reporting to senior leadership
- Experience working with Data & AI related technologies, including, but not limited to, AI/ML, GenAI, Analytics, Database, and/or Storage
- Regulatory Affairs Certification (RAPS)
Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status.
Los Angeles County applicants: Job duties for this position include: work safely and cooperatively with other employees, supervisors, and staff; adhere to standards of excellence despite stressful conditions; communicate effectively and respectfully with employees, supervisors, and staff to ensure exceptional customer service; and follow all federal, state, and local laws and Company policies. Criminal history may have a direct, adverse, and negative relationship with some of the material job duties of this position. These include the duties and responsibilities listed above, as well as the abilities to adhere to company policies, exercise sound judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness and professionalism, and safeguard business operations and the Company’s reputation. Pursuant to the Los Angeles County Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you’re applying in isn’t listed, please contact your Recruiting Partner.
The base salary range for this position is listed below. Your Amazon package will include sign-on payments and restricted stock units (RSUs). Final compensation will be determined based on factors including experience, qualifications, and location. Amazon also offers comprehensive benefits including health insurance (medical, dental, vision, prescription, Basic Life & AD&D insurance and option for Supplemental life plans, EAP, Mental Health Support, Medical Advice Line, Flexible Spending Accounts, Adoption and Surrogacy Reimbursement coverage), 401(k) matching, paid time off, and parental leave. Learn more about our benefits at https://amazon.jobs/en/benefits.
LOCATION
USA, CA, Sunnyvale
COMPENSATION
- Salary Range: $171,000.00 - $231,400.00 USD annually
DESCRIPTION
Amazon Devices and Services is an innovative research and development company that designs and engineers high-profile consumer electronics. We are known for creating the Kindle family of products, and devices like Fire tablets, Fire TV and Echo Frames. Working as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in class products.
The ideal candidate will have experience building a regulatory strategy and supporting documents from scratch, including developing, leading, and driving proactive execution of a global regulatory strategy. They must enjoy problem solving and possess practical hands-on knowledge of FDA submissions and reporting requirements across the product lifecycle for medical products.
ROLE AND RESPONSIBILITIES
- Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements.
- Develops global regulatory strategies for new and modified products.
- Prepares and submits regulatory submissions to health agencies.
- Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures.
- Provides regulatory assessment for manufacturing, design changes and product risk assessment.
- Reviews and advises on labeling, product claims, marketing brochures, advertising and promotional material and other publications to ensure compliance with regulations.
- Plans, schedules, and arranges all activities to support regulatory timelines.
- Partners with quality system leadership to maintain regulatory and quality compliance requirements, including support during regulatory audits.
- Maintains annual licenses, registrations, and listing information. Assists with compliance to product post-marketing approval requirements.
- Supports the product release process.
- Acts as an SME for internal and external audits and inspections by internal teams or external regulatory authorities.
- Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, company policies, and governing procedures and processes.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Reviews protocols and reports to support regulatory submissions.
- Creates, reviews and approves engineering change requests.
- Acts as liaison between the Company and the various regulatory agencies. Interfaces directly with FDA and Notified Bodies.
- Provide interpretation of regulatory authorities’ feedback, policies and guidelines.
- Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills as evidenced by past performance on drug development project teams.
ABOUT THE TEAM
The Quality & Lean, Medical Devices Operational Compliance Center (MD-OCC), consists of business process analysts, quality system experts, program managers, supply chain experts, regulatory experts, clinical affairs, and internal auditors. Our mission is to establish and manage Amazon Devices and Services Medical Product Quality and Regulatory Systems; enabling the manufacture and distribution of safe, effective and high-quality medical products for at home, mobile health and wellness customers.
BASIC QUALIFICATIONS
- 7+ years of working directly with engineering teams experience
- 5+ years of technical product or program management experience
- 5+ years of technical program management working directly with software engineering teams experience
- Experience managing programs across cross functional teams, building processes and coordinating release schedules
- Experience with regulatory filings and reports or equivalent
- Experience that includes strong analytical skills, attention to detail, and effective communication abilities, or experience working with customers with a passion for delivering exceptional service
- Experience working on multi-team, cross-disciplinary projects
- Experience that includes strong analytical skills, attention to detail, and effective communication abilities
- Experience in identifying incomplete or inaccurate data, identifying the root cause and creating/implementing an escalation plan, or experience communicating results to senior leadership
- Bachelor’s Degree in Scientific discipline e.g. Biomedical Engineering, life Sciences, Biology (or equivalent qualifications)
- 5 years of experience working within the requirements of 21 CFR 820, ISO13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
- 5 years of experience in a regulated industry with experience working with Class II and/or Class III devices.
- Knowledge and understanding of guiding principles in device development such as benefit/risk profile, statistical design or drug dose selection
- Experience with medical device software requirements.
PREFERRED QUALIFICATIONS
- 5+ years of project management disciplines including scope, schedule, budget, quality, along with risk and critical path management experience
- Experience managing projects across cross functional teams, building sustainable processes and coordinating release schedules
- Experience defining KPI's/SLA's used to drive multi-million dollar businesses and reporting to senior leadership
- Experience working with Data & AI related technologies, including, but not limited to, AI/ML, GenAI, Analytics, Database, and/or Storage
- Regulatory Affairs Certification (RAPS)
Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status.
Los Angeles County applicants: Job duties for this position include: work safely and cooperatively with other employees, supervisors, and staff; adhere to standards of excellence despite stressful conditions; communicate effectively and respectfully with employees, supervisors, and staff to ensure exceptional customer service; and follow all federal, state, and local laws and Company policies. Criminal history may have a direct, adverse, and negative relationship with some of the material job duties of this position. These include the duties and responsibilities listed above, as well as the abilities to adhere to company policies, exercise sound judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness and professionalism, and safeguard business operations and the Company’s reputation. Pursuant to the Los Angeles County Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you’re applying in isn’t listed, please contact your Recruiting Partner.
The base salary range for this position is listed below. Your Amazon package will include sign-on payments and restricted stock units (RSUs). Final compensation will be determined based on factors including experience, qualifications, and location. Amazon also offers comprehensive benefits including health insurance (medical, dental, vision, prescription, Basic Life & AD&D insurance and option for Supplemental life plans, EAP, Mental Health Support, Medical Advice Line, Flexible Spending Accounts, Adoption and Surrogacy Reimbursement coverage), 401(k) matching, paid time off, and parental leave. Learn more about our benefits at https://amazon.jobs/en/benefits.
LOCATION
USA, CA, Sunnyvale
COMPENSATION
- Salary Range: $171,000.00 - $231,400.00 USD annually
See All 19 Regulatory Affairs Specialist Jobs in California
Find roles in California that match your experience and apply in just a few clicks.
Find JobsRegulatory Affairs Specialist Jobs by City in California
Where California roles are concentrated, by current openings.
Regulatory Affairs Specialist Job Market in California
A snapshot from current California openings, updated as new roles post.
Who's Hiring
- Abbott4
- Procept BioRobotics3
- Edwards Lifesciences2
- Evalve2
- Intuitive (Intuitive Surgical)2
Top Industries Hiring
- Biotechnology & Pharmaceuticals8
- Medical Devices8
- Technology & Software2
- Distribution & Wholesale1
- Healthcare & Medical Services1
What California Employers Look For
The qualifications that appear most often in regulatory affairs specialist jobs across California.
- Bachelor's degree in life sciences, engineering, pharmacy, or a related scientific field
- Experience with FDA submissions including 510(k), PMA, BLA, or NDA filings
- Working knowledge of 21 CFR Part 11, Part 820, and ISO 13485 quality standards
- Familiarity with California Department of Public Health requirements for medical product manufacturers
- Proficiency with regulatory information management systems such as Veeva Vault or MasterControl
- Strong technical writing skills for preparing regulatory strategies, dossiers, and labeling documents
Regulatory Affairs Specialist Jobs in California: Frequently Asked Questions
How do you become a regulatory affairs specialist in California?
Most regulatory affairs specialists in California enter the field with a bachelor's degree in biology, chemistry, pharmacy, biomedical engineering, or a closely related science. California employers strongly favor candidates who have earned the Regulatory Affairs Certification from the Regulatory Affairs Professionals Society. Many also pursue a master's degree in regulatory science, a program offered by several University of California campuses and USC, to move into senior roles faster.
How much do regulatory affairs specialists make in California?
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 regulatory affairs specialists in California?
Employers hiring regulatory affairs specialists in California right now include Abbott, Procept BioRobotics, and Edwards Lifesciences, based on current listings on Migrate Mate as of June 2026. California's dense concentration of medical device and biopharmaceutical headquarters, particularly in San Diego's Torrey Pines corridor and the Bay Area, means a steady volume of openings across both large corporations and well-funded clinical-stage companies.
Which California cities have the most regulatory affairs specialist jobs?
The cities with the most regulatory affairs specialist openings in California are Alameda, Irvine, and San Jose. San Diego and the Bay Area dominate because they anchor California's two largest life sciences clusters, while Los Angeles draws consistent demand from its growing medical device and pharmaceutical manufacturing base.
Are there remote regulatory affairs specialist jobs in California?
Yes, and more than most scientific roles, because much of the work involves document review, dossier preparation, and agency correspondence rather than lab or manufacturing floor presence. About 0% of regulatory affairs specialist openings tied to California are remote or hybrid as of June 2026, reflecting how document-driven the role is. Submissions management, labeling review, and regulatory strategy work are the functions most commonly offered remotely.
How can I get hired as a regulatory affairs specialist in California with little or no experience?
The most realistic entry path is a regulatory affairs associate or coordinator role, which large California medical device and biotech employers post specifically for candidates without direct regulatory experience. Companies like Becton Dickinson and Hologic, both with California operations, regularly hire science graduates into associate programs that rotate through submissions, labeling, and compliance teams. A relevant internship completed through a UC San Diego or UCSF regulatory science program, or lateral experience in quality assurance or clinical operations, is the credential that opens the door most reliably.
Where can I find and apply to regulatory affairs specialist jobs in California?
You can find and apply to regulatory affairs specialist jobs in California on Migrate Mate, which lists current California openings across medical devices, biotechnology, pharmaceuticals, and combination products. Find roles that fit your background and apply directly.
See All 19 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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