Regulatory Affairs Jobs in Washington
Regulatory affairs jobs in Washington are consistently in demand, with strong hiring concentrated in the life sciences, biotechnology, medical device, and pharmaceutical sectors that anchor the state's economy from Seattle and Bellevue to the Puget Sound corridor. Most openings range from entry-level regulatory associates through senior managers and directors, with the Seattle metro, Bothell, and Redmond drawing the heaviest volume of postings. Established employers with deep roots in the state include Seagen, Abbott, and the University of Washington Medical Center. The most sought-after specialties are FDA submissions, quality systems compliance, and clinical regulatory strategy. Find a role that fits below and apply directly.
Find Regulatory Affairs JobsOverview
Showing 5 of 11+ Regulatory Affairs jobs
DESCRIPTION
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.
Key job 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.
USA, WA, Bellevue - 148,700.00 - 201,200.00 USD annually
DESCRIPTION
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.
Key job 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.
USA, WA, Bellevue - 148,700.00 - 201,200.00 USD annually
See All 11 Regulatory Affairs Jobs in Washington
Find roles in Washington that match your experience and apply in just a few clicks.
Find Regulatory Affairs JobsRegulatory Affairs Jobs by City in Washington
Where Washington roles are concentrated, by current openings.
Regulatory Affairs Job Market in Washington
A snapshot from current Washington openings, updated as new roles post.
Who's Hiring
Top Industries Hiring
- Biotechnology & Pharmaceuticals
What Washington Employers Look For
The qualifications that appear most often in regulatory affairs jobs across Washington.
- Bachelor's degree in life sciences, engineering, pharmacy, or a related technical field
- Knowledge of FDA regulatory pathways including 510(k), PMA, or drug approval processes
- Experience preparing and submitting regulatory submissions to federal or international agencies
- Familiarity with quality management systems such as ISO 13485 or 21 CFR Part 820
- Strong technical writing skills for preparing regulatory documents and dossiers
- Experience with Washington-based biotechnology, medical device, or pharmaceutical product development
Regulatory Affairs Jobs in Washington: Frequently Asked Questions
How do you become a regulatory affairs professional in Washington?
Most regulatory affairs roles in Washington require at minimum a bachelor's degree in a life science, engineering, or pharmacy discipline, with employers in the state's medical device and biotech sectors strongly preferring candidates with hands-on product development experience. While Washington does not issue a state-specific regulatory affairs license, earning the Regulatory Affairs Certification through the Regulatory Affairs Professionals Society is widely recognized by Washington employers and significantly improves hiring prospects.
How much do regulatory affairses make in Washington?
Regulatory affairses in Washington earn a median of about $88,790 a year, based on May 2025 Bureau of Labor Statistics wage data, ranging from around $60,650 for the lowest 10% to over $142,350 for the top 10%. Pay rises with experience, specialty, and employer.
Which companies hire regulatory affairs professionals in Washington?
Employers hiring regulatory affairs professionals in Washington right now include Stryker, Adaptive Biotechnologies, and lululemon, based on current listings on Migrate Mate as of November 2026. Washington's dense concentration of medical device and biotech companies, particularly in the Bothell and greater Seattle corridor, means a broad range of established and growing organizations post regulatory roles throughout the year.
Which Washington cities have the most regulatory affairs jobs?
Seattle, Redmond, and Bothell are the Washington cities with the most regulatory affairs openings, reflecting the concentration of life sciences, medical device manufacturers, and biotech firms headquartered in and around the greater Seattle metro and its key suburban employment centers in Snohomish and King counties.
Are there remote regulatory affairs jobs in Washington?
Yes, and more than many technical fields, because much of the work involves document preparation, agency correspondence, and submissions review that can be done off-site. About 71% of regulatory affairs openings tied to Washington are remote or hybrid as of November 2026, with fully remote roles most common in regulatory writing, submissions management, and compliance advisory positions rather than roles tied to lab or manufacturing environments.
How can I get hired as a regulatory affairs professional in Washington with little or no experience?
The most realistic entry path is a regulatory affairs associate or coordinator role at one of Washington's many medical device or biotech companies, where companies like Seagen and Philips Healthcare regularly bring in candidates from adjacent backgrounds such as quality assurance, clinical research coordination, or laboratory science. Completing the Regulatory Affairs Professionals Society's foundation courses and earning a RAC credential strengthens your application considerably. Many University of Washington or Washington State University graduate programs also offer regulatory science concentrations that provide both credentials and direct industry connections in the state.
Where can I find and apply to regulatory affairs jobs in Washington?
You can find and apply to regulatory affairs jobs in Washington on Migrate Mate, which lists current openings from employers actively hiring across the state. Search the current listings, find roles that fit your background and location, and apply directly to the ones that match.
See All 11 Regulatory Affairs Jobs in Washington
Find roles in Washington that match your experience and apply in just a few clicks.
Find Regulatory Affairs Jobs