Senior Manager, License Compliance
Tanium
Principal Regulatory Affairs Specialist
Diabetes Youth Families
full-time
Posted on:
Location: Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $109,125 - $163,688 per year
Job Level
Lead
Tech Stack
Cloud
About the role
- Lead strategic regulatory initiatives and projects to ensure regulatory approval and compliance of medical devices in both domestic and international markets. Provide regulatory affairs expertise for aspects of product development, product manufacturing, and/or clinical studies including pre-market, post-market and physician initiated studies. Provide Regulatory support to on-going compliance and corporate initiatives.
- Compile and submit documentation as required in support of marketing initiatives.
- Represent Regulatory Affairs on strategy and compliance project teams in areas of expertise .
- Lead or support the expert review of pre-market filings as appropriate ( Q-Sub, 510(k), IDE, PMA, PMA updates, CE Marking, Canadian Registrations, EU Registrations, and ROW registrations).
- Lead in planning, creating, organizing and interpreting regulatory documents for strategic regulatory initiatives .
- Review and approve project documentation such as specifications, procedures, schedules, test protocols and reports, validations, etc , as required depending on project .
- Performs other duties as required.
Requirements
- B.S. / B.A. or equivalent combination of education and experience.
- 8 + years of regulatory medical device industry experience.
- RAC Certification preferred.
- Knowledge of regulatory guidelines and requirements (domestic and international).
