Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human Factors
Core
Lead the development and implementation of innovative regulatory strategies for pure devices and drug-device combinations, with a specific focus on Human Factors to ensure high-quality regulatory filings.
Role type
Senior Director and Regulatory Platform Lead (Human Factors)
Builds
Global regulatory strategies, briefing books, and compliance frameworks for drug-device combination products.
Domain
Pharmaceuticals and Medical Devices (Regulatory Affairs)
Required skills
Human Factors expertise, regulatory strategy for combination products, design control, global health authority interaction (FDA/EMA), stakeholder influence, team leadership
Preferred skills
International regulatory experience, advanced degree in scientific/engineering discipline, experience with Notified Bodies
Technologies
Regulatory submission formats (IND, CTA, BLA, MAA, 510(k), Technical Files)
Responsibilities
Author and review regulatory strategies and briefing books for global health authorities; Lead regulatory strategy meetings; Review and approve design control documentation including human factors protocols; Develop training and tools for the regulatory team; Identify and communicate regulatory risks; Support global regulatory submissions.
Seniority
Senior Director, strategic leadership with hands-on regulatory guidance