Principal Scientist, CMC Regulatory Affairs – Medical Devices & Combination Products
Core
Strategic leadership for global CMC regulatory activities supporting medical devices, drug-device combination products, and associated regulatory programs across development, registration, and lifecycle management.
Role type
Principal Scientist, CMC Regulatory Affairs (Medical Devices & Combination Products)
Builds
Global regulatory strategies and submissions for complex device and combination product programs
Domain
Healthcare / Medical Devices / Combination Products / Regulatory Affairs
Required skills
Global regulatory strategy, FDA/EMA engagement, IND/CTA/NDA/BLA/MAA submissions, Design controls, Risk management, Human factors engineering, Usability validation, Cross-functional leadership, Inspection readiness, ISO 13485/14971/IEC 62366 knowledge, Biologic/pharmaceutical portfolio experience
Preferred skills
Advanced degree (MS, PharmD, PhD, MBA), Industry trade group participation, Global market expansion experience
Technologies
None stated
Responsibilities
Develop global CMC regulatory strategies, Lead major regulatory submissions (INDs, CTAs, NDAs, BLAs, MAAs), Represent organization with health authorities (FDA, EMA, Health Canada), Guide teams on device requirements (Design controls, Risk management, Human factors), Drive regulatory process improvements and capability building
Seniority
Principal, strategic leadership & cross-functional influence