Lead regulatory activities including 510(k), pre-submissions, and De Novo filings, and maintain compliance with FDA and applicable regulations. Oversee and maintain the electronic Quality Management System (eQMS), including audits, CAPA, and design history files. Partner with cross-functional leadership (Engineering, Legal, Executive Team) to define regulatory pathways and strategies.
Requirements
- Bachelor’s degree in Engineering, Science, or related field (advanced degree preferred)
- 3–5+ years of regulatory affairs experience in medical devices, SaMD, or similar environment
- Experience with eSTAR, eQMS platforms, and FDA submission processes
Benefits
- Competitive Benefits package
- Compensation Reviews
- Career Growth Opportunities
- Flexible Remote Schedules
- Generous PTO Plans and Paid Holidays
