Sr. Regulatory Affairs Specialist II
$120,000–$135,000 year
Hybrid · Del Mar, California, United States
Job Summary
Sr. Regulatory Affairs Specialist II leads worldwide regulatory strategies for medical devices, including submissions (510(k), De Novo, CE Mark) and liaises with FDA, Health Canada, and EU regulators. Responsible for regulatory assessments of design/manufacturing changes, ensuring compliance with GMP, ISO 13485, 21 CFR Parts 820/803/806, and applicable EU/UK requirements (MDR/MDD). Focus areas include Digital Health and SaMD; provides regulatory guidance to product teams, reviews promotional materials for compliance, and leads interactions during regulatory inspections. Experience with coordinating global regulatory submissions, maintaining existing products, and navigating international regulatory requirements is required; Bachelor's degree in a relevant field and 7+ years of regulatory experience in medical devices or health IT; Regulatory Affairs Certification (RAC) desirable.
Required Qualifications
- Bachelor's degree in Science, Regulatory Affairs, Technology, Engineering, or Mathematics, or equivalent combination of education and applicable job experience
- Regulatory Affairs Certificate, preferred
- Certification (RAC) by the Regulatory Affairs Professional Society or other documented past training in medical device regulations, desirable
- 7+ years of related experience in regulatory function in medical device or health IT industry
- Experience leading, designing, writing, and submission of regulatory filings and correspondence (e.g., 510(k), De Novo, CE Mark) and preparing regulatory submissions for product commercialization
- Strong knowledge of ISO 13485, 21CFR Part 820 and GMP; knowledge of IEC 60601-series standards; experience with SaMD and software in medical devices
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