Senior Regulatory Affairs Specialist (Hybrid)
Core
Support the continued compliance, registration, and market availability of medical devices throughout their lifecycle by partnering with cross-functional teams on product changes and regulatory activities.
Role type
Senior Regulatory Affairs Specialist
Builds
Regulatory submissions, strategies, and compliance activities for medical devices
Domain
Medical Devices / Healthcare
Required skills
Regulatory assessments, market access analysis, regulatory strategy development, product classification, submission preparation, regulatory authority communication, change management
Preferred skills
SaMD support, RAC certification, Class II/III device experience, submission authoring, agency interaction
Technologies
Electronic regulatory submission systems
Responsibilities
Support R&D, Marketing and Manufacturing teams with regulatory assessments; Identify requirements and potential obstacles for market access; Evaluate proposed products for regulatory classification; Prepare and submit electronic and paper regulatory submissions; Communicate with regulatory authorities; Maintain current product registrations