Sr. Regulatory Affairs Specialist , Medical Devices Operational Compliance Center (MD-OCC)

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.

- 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
- Bachelors 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.

- 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 KPIs/SLAs 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 Companys 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 for more information. If the country/region youre applying in isnt 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 CA Sunnyvale - 171000.00 - 231400.00 USD annually