Senior Specialist Device Technical Regulatory
Core
Lead device program teams in implementing regulatory strategies and ensuring compliance for medical devices and drug-device combination products across EU and US markets.
Role type
Senior Specialist Device Technical Regulatory
Builds
Regulatory submission content (NDA, ANDA, BLA, MAA) and regulatory plans for global device development programs.
Domain
Healthcare / Medical Devices / Drug-Device Combination Products
Deliverable
client delivery
Required skills
FDA and EU regulations knowledge, ISO standards application, regulatory strategy development, team leadership, regulatory document authoring, problem solving in regulatory issues
Preferred skills
Masters degree, experience in drug delivery focus
Technologies
21 CFR 820, MDR (EU) 2017/745, ISO 13485
Responsibilities
Lead Device Program Teams in execution of regulatory strategies, generate regulatory plans aligned with program timelines, author and review documents for regulatory submissions, provide feedback on agency outcomes, support team learning and development
Seniority
Senior, hands-on IC