Regulatory Affairs Analyst Jobs in Washington
Regulatory affairs analyst jobs in Washington are among the most active in the country, concentrated in the state's life sciences, medical device, and biotechnology sectors, with openings at every level from entry-level associate to senior compliance lead. The heaviest hiring is in and around Seattle, Bothell, and Kirkland, where established employers such as Philips, Stryker, and Amazon Pharmacy maintain significant regulatory operations. The most in-demand specialties are FDA submissions and 510(k) filings, pharmaceutical quality systems, and post-market surveillance. Scan the live roles below and apply to whichever ones fit.
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Showing 5 of 11+ Regulatory Affairs Analyst 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 Analyst Jobs in Washington
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Find JobsRegulatory Affairs Analyst Jobs by City in Washington
Where Washington roles are concentrated, by current openings.
Regulatory Affairs Analyst 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 analyst jobs across Washington.
- Bachelor's degree in life sciences, chemistry, engineering, or a related technical field
- Working knowledge of FDA regulations, including 21 CFR Parts 820 and 211
- Experience preparing or supporting regulatory submissions such as 510(k) or BLA filings
- Familiarity with quality management systems including ISO 13485 or ICH guidelines
- Strong technical writing skills for preparing regulatory documents and SOPs
- RAC credential from the Regulatory Affairs Professionals Society preferred by many employers
Regulatory Affairs Analyst Jobs in Washington: Frequently Asked Questions
How do you become a regulatory affairs analyst in Washington?
Most employers in Washington require a bachelor's degree in a life science, chemistry, engineering, or pharmacy-related field as the foundation. Washington does not issue a state-specific license for regulatory affairs analysts, so candidates advance by building hands-on experience with FDA submissions, quality systems, or clinical documentation. Earning the RAC credential from the Regulatory Affairs Professionals Society strengthens a candidate's profile considerably and is frequently listed in Washington job postings at the mid and senior levels.
Which companies hire regulatory affairs analysts in Washington?
Employers hiring regulatory affairs analysts in Washington right now include Stryker, Adaptive Biotechnologies, and lululemon, based on current listings on Migrate Mate as of November 2026. Washington's concentration of medical device and biotech firms means demand is particularly consistent along the Bothell and Kirkland corridors, where contract research organizations and established device manufacturers maintain large regulatory teams.
Which Washington cities have the most regulatory affairs analyst jobs?
The cities with the most regulatory affairs analyst openings in Washington are Seattle, Redmond, and Bothell. Seattle anchors the market as the headquarters hub for major biotech, pharmaceutical, and digital health employers, while Bothell and Kirkland draw strong demand from the dense cluster of medical device and life sciences companies that have built operations in the greater Eastside corridor.
Are there remote regulatory affairs analyst jobs in Washington?
Yes, and more than most fields. About 71% of regulatory affairs analyst openings tied to Washington are remote or hybrid as of November 2026, reflecting the desk-based and documentation-heavy nature of the work. Roles focused on regulatory writing, submissions strategy, and labeling review tend to be the most remote-compatible, while positions requiring direct lab or manufacturing floor involvement are more likely to be on-site.
How can I get hired as a regulatory affairs analyst in Washington with little or no experience?
The most realistic entry path is a lateral move from a quality assurance, clinical research, or regulatory documentation role at a Washington medical device or biotech company. Large Washington employers such as Philips and contract research organizations operating out of Bothell and Seattle regularly post regulatory associate and coordinator roles that are structured for candidates with limited direct RA experience. Building familiarity with FDA 510(k) submissions through academic projects or internships and pursuing the RAC foundation credential gives early-career candidates a concrete edge in applications.
Where can I find and apply to regulatory affairs analyst jobs in Washington?
You can find and apply to regulatory affairs analyst jobs in Washington on Migrate Mate, which lists current Washington openings. Search the available roles, find the ones that match your background and target industry, and apply directly to the ones that fit.
See All 11 Regulatory Affairs Analyst Jobs in Washington
Find roles in Washington that match your experience and apply in just a few clicks.
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