Amazon - Bellevue, WA
posted about 2 months ago
Full-time - Mid Level
Bellevue, WA
10,001+ employees
Sporting Goods, Hobby, Musical Instrument, Book, and Miscellaneous Retailers
About the position
The Sr. Regulatory Affairs Specialist at Amazon Devices and Services will play a crucial role in ensuring compliance with regulatory requirements for medical devices. This position involves developing and executing global regulatory strategies, preparing submissions to health agencies, and acting as a regulatory representative on product development teams. The specialist will work closely with engineering teams and quality system leadership to maintain compliance and support the product release process, ensuring that Amazon's medical products meet safety and quality standards.
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.
- Provides interpretation of regulatory authorities' feedback, policies and guidelines.
Requirements
- 5+ years of working directly with engineering teams experience
- 5+ years of technical product or program management experience
- Experience managing programs across cross functional teams, building processes and coordinating release schedules
- Bachelor's Degree in Scientific discipline e.g. Biomedical Engineering, life Sciences, Biology (or equivalent qualifications)
- 5-7 years of experience in regulatory submissions for In Vitro Diagnostic Devices, Pharmaceutical and/or Biologics (small molecules & biologics)
- 5-7 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)
- 5-7 years of experience in a regulated industry with experience working with biologics and/or Class II and/or Class III devices
- Prior experience with phase 1, 2 and 3 design including end of phase health authority interactions
- Knowledge and understanding of guiding principles in device and drug development such as benefit/risk profile, statistical design or drug dose selection
- Ability to work effectively on project teams
- Strong attention-to-detail
- Strong written, verbal, presentation, and organizational skills
- Experience with medical device software requirements
- Ability to identify risk areas and escalate issues as appropriate
Nice-to-haves
- Experience defining KPI's/SLA's used to drive multi-million dollar businesses and reporting to senior leadership
- Regulatory Affairs Certification (RAPS)
- Drug and Biologics regulatory filing experience
Benefits
- Medical, financial, and other benefits
- Equity and sign-on payments as part of total compensation package
