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
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)
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, CA, Sunnyvale - 171,000.00 - 231,400.00 USD annually
