Principal Regulatory Affairs Specialist
Core
Develop and execute regulatory strategies for innovative medical devices, managing submissions to the FDA and EU notified bodies.
Role type
Principal Regulatory Affairs Specialist
Builds
Regulatory submissions (PMA, 510(k), CE marking) and global product registrations for medical devices
Domain
Medical Devices / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy, FDA submission management, EU MDR compliance, cross-functional collaboration, technical writing, project management
Preferred skills
Class II/III device experience, design controls knowledge, international regulations expertise, multi-project prioritization
Technologies
Microsoft Word, Excel, PowerPoint, Adobe Acrobat
Responsibilities
Coordinate and submit U.S. and EU regulatory filings (PMA, 510(k), CE marking); Develop domestic and international regulatory strategies; Provide regulatory training to cross-functional teams; Review product design and manufacturing changes for compliance; Evaluate labeling and promotional materials for regulatory compliance; Collaborate with international teams for global registrations; Support regulatory audits and inspections.
Seniority
Principal, strategic execution & mentorship