Staff Regulatory Affairs Specialist
Core
Lead regulatory affairs activities to obtain and maintain market authorization for new and modified medical devices in the US, Europe, and international markets.
Role type
Staff Regulatory Affairs Specialist (Medical Devices)
Builds
Regulatory submissions (510(k), PMA, IDE), technical files, and compliance strategies for medical device product lifecycle.
Domain
Medical Technology / Regulatory Affairs
Required skills
Regulatory submission preparation (510(k), PMA, IDE), FDA liaison, international registration dossiers, risk-based decision-making, SOP development, cross-functional collaboration, technical/clinical data evaluation.
Preferred skills
Experience with FDA Class II/III devices, product lifecycle management, complex regulatory issue resolution.
Technologies
FDA 510(k), PMA, IDE, ISO 13485, IEC 62304
Responsibilities
Coordinate FDA Premarket Notification 510(k) submissions and act as liaison with FDA; Assess necessity for 510(k) applications and prepare Non-Filing Justifications; Prepare technical files for International Registrations; Review and approve labeling and promotional materials; Represent RA in product life cycle and design teams; Support International Registrations for product changes and new launches; Write and update SOPs and work instructions.
Seniority
Staff, independent analysis and leadership