--- title: Sr. Regulatory Affairs Specialist at Amazon description: Amazon is hiring for the Sr. Regulatory Affairs Specialist role in Bellevue, WA. Full-time role. See the full description and apply. type: job url: https://www.foundrole.com/jobs/sr-regulatory-affairs-specialist-at-amazon-01a0b3c6-a49e-765b-89e3-506f65ecec69 date: 2026-11-15T01:26:44Z og_description: Join Amazon as Sr. Regulatory Affairs Specialist in Bellevue, WA. Pays $148.7K–$201.2K per year. Full-time role. og_image: https://www.foundrole.com/og/52m10i.png breadcrumbs: - label: Home url: https://www.foundrole.com/ - label: Search url: https://www.foundrole.com/jobs --- | | | |---|---| | **Company** | [Amazon](https://www.foundrole.com/companies/amazon?utm_source=ai_markdown) | | **Location** | Bellevue, WA | | **Salary** | $148.7K/yr - $201.2K/yr | | **Type** | Full Time | | **Posted** | Oct 26, 2026 | ## Is this job real? **Ghost job check:** A · Low risk. Probably a real opening. ## Visa sponsorship - **H-1B:** Amazon sponsors H-1B visas. It filed 25,968 H-1B petitions (FY2026 Q1 – FY2026 Q4). - **E-Verify:** No E-Verify enrollment on record for Amazon. ## Pay for similar jobs Most similar jobs pay $143,000 – $186,000 a year (median $162,000). ## 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. 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. 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 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 . USA, WA, Bellevue - 148,700.00 - 201,200.00 USD annually ## Skills - Service-Level Agreement - Project Management - Quality Management System (Qms) - Inspection - Analytics - Subject Matter Expertise - Regulatory Filing - Program Management - Analytical Skills - Problem Solving - Critical Path Method (Cpm) Scheduling - Database Management - Key Performance Indicators (KPIs) - Critical Thinking - Risk Management - Negotiation - Licensing - Root Cause Analysis - External Audit - Artificial Intelligence - Medical Devices - ISO 13485 - Regulatory Submissions - Compliance Auditing - FDA 21 CFR Part 820 - Collaboration - Quality Compliance - Generative AI - Refugee, Asylum and Parole System RAPS - Regulatory Affairs Certification - Coordinating - Release Management - Engineering Change Management - Attention to Detail - Drug Administration - Leadership - Regulatory Strategy - FDA Regulations - Communication - In Vitro Diagnostics (Ivd) - Machine Learning - Drug Development - Regulatory Compliance ## Benefits - Mental Health - Health Insurance - Dental Insurance - Vision Insurance - Life Insurance - Parental Leave - Paid Time Off (Pto) - 401(k) Plans - Employee Stock Options (ESOs) ## Related - [More jobs at Amazon](https://www.foundrole.com/companies/amazon?utm_source=ai_markdown) - [Legal & Compliance jobs](https://www.foundrole.com/careers/legal-and-compliance?utm_source=ai_markdown)- [Compliance & Regulatory jobs](https://www.foundrole.com/careers/legal-and-compliance/compliance-and-regulatory?utm_source=ai_markdown)- [Regulatory Affairs Specialist jobs](https://www.foundrole.com/careers/legal-and-compliance/compliance-and-regulatory/regulatory-affairs-specialist?utm_source=ai_markdown)- [Browse all companies](https://www.foundrole.com/companies?utm_source=ai_markdown) ## Explore this job market - [Internet Marketplace Platforms](https://www.foundrole.com/sectors/technology/internet-marketplace-platforms?utm_source=ai_markdown) — 63042 jobs - [Washington](https://www.foundrole.com/locations/us/washington?utm_source=ai_markdown) — 61444 jobs - [Amazon](https://www.foundrole.com/companies/amazon?utm_source=ai_markdown) — 20341 jobs - [Bellevue, WA](https://www.foundrole.com/locations/us/washington/bellevue?utm_source=ai_markdown) — 4733 jobs ## Related pages - [Internet Marketplace Platforms](https://www.foundrole.com/sectors/technology/internet-marketplace-platforms?utm_source=ai_markdown) — 63042 jobs - [Washington](https://www.foundrole.com/locations/us/washington?utm_source=ai_markdown) — 61444 jobs - [Amazon](https://www.foundrole.com/companies/amazon?utm_source=ai_markdown) — 20341 jobs - [Bellevue, WA](https://www.foundrole.com/locations/us/washington/bellevue?utm_source=ai_markdown) — 4733 jobs ## Browse - [Companies](https://www.foundrole.com/companies?utm_source=ai_markdown) - [Jobs by country](https://www.foundrole.com/locations?utm_source=ai_markdown) - [Jobs in the United States by state and city](https://www.foundrole.com/locations/us?utm_source=ai_markdown) - [H1B sponsors by location](https://www.foundrole.com/h1b-sponsors?utm_source=ai_markdown) - [H1B salaries](https://www.foundrole.com/h1b-salaries?utm_source=ai_markdown) - [Sectors and industries](https://www.foundrole.com/sectors?utm_source=ai_markdown) - [Jobs by career field](https://www.foundrole.com/careers?utm_source=ai_markdown) - [Latest jobs](https://www.foundrole.com/jobs/latest?utm_source=ai_markdown)