Regulatory Affairs professional specializing in the medical device industry, with extensive international (global) submission and registration renewal experience (e.g., EU, Health Canada, Brazil, LATAM, China).

 

Core competencies include technical file remediation, regulatory agency and notified body interaction (written responses), and cross-functional support activities (e.g., regulatory assessments for product-related changes; advertising and promotional review).

 

Pre-Market Approval (PMA) Annual Reports (FDA).

 

Regulatory Affairs Certified (RAC) – Regulatory Affairs Professional Society (RAPS)