Principal RA Associate Devices
Core
Develops regulatory strategies and prepares submissions to market new or modified medical devices in domestic and international clinical markets.
Role type
Principal Regulatory Affairs Associate (Medical Devices)
Builds
Regulatory submissions (510(k), PMA, IDE) and compliance systems for medical device product lines
Domain
Medical Devices / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA submission strategy, 510(k) preparation, PMA preparation, IDE submissions, regulatory risk assessment, procedure development, project management, cross-functional collaboration
Preferred skills
International regulatory knowledge, supervisory experience, advanced degree
Technologies
Microsoft Office
Responsibilities
Develop regulatory strategies for assigned products, prepare FDA submissions (510(k), PMA, IDE), provide guidance on regulatory requirements to product development teams, coordinate responses to regulatory agency requests, review and approve engineering changes and promotional materials, develop and maintain regulatory procedures, assist with regulatory agency interactions, manage assigned projects and resources
Seniority
Principal, hands-on IC with leadership responsibilities
