معرفی
Nancy Cameron serves as a Lecturer in Regulatory Science & Medical Device Development at the University of St. Thomas School of Engineering, leveraging over 30 years of industry experience in medical device and pharmaceutical regulation.
Her academic credentials include:
- MS in Regulatory Affairs & Sciences from St. Cloud State University
- BS in Chemistry from University of Wisconsin, Oshkosh
Her research focuses on regulatory strategy for combination products, analytical method validation, and global submission frameworks. She specializes in navigating FDA pathways for medical devices (CDRH), pharmaceuticals (CDER), and biologics (CBER), with particular expertise in CMC sections for NDA/ANDA submissions and European regulatory dossiers. Her work bridges scientific innovation with compliance requirements across the product lifecycle.
Professional recognitions include:
- CQA (Certified Quality Auditor) from American Society for Quality
- CPGP (Certified Pharmaceutical GMP Professional) from American Society for Quality
- RAC (Regulatory Affairs Certification) US from Regulatory Affairs Professional Society
As a Distinguished Regulatory Affairs Advisor at Medtronic supporting Cardiac Rhythm Management products, she integrates industry practice with academic instruction. Her Fall 2025 course ETLS 731 explores combination product regulation, emphasizing FDA center jurisdiction determinations and post-market requirements.
