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

Amazon • Sunnyvale, CA

1d • $171,000 - $231,400 • Onsite

About The Position

Amazon Devices and Services is seeking a Sr. Regulatory Affairs Specialist to join the Medical Devices Operational Compliance Team (MD-OCC). This role will be instrumental in building best-in-class medical products by developing and executing global regulatory strategies. The ideal candidate will have hands-on experience with FDA submissions, reporting requirements, and managing the regulatory aspects of products throughout their lifecycle. This position requires strong problem-solving skills and the ability to build regulatory strategies and supporting documents from the ground up.

Requirements

• 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.

Nice To Haves

• 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)

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.
• Demonstrates critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills as evidenced by past performance on drug development project teams.

Benefits

• 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
• parental leave
• sign-on payments
• restricted stock units (RSUs)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior