Regulatory Affairs Specialist
Core
Performs regulatory assessments for product changes and line extensions, reviews marketing collateral for compliance, and monitors regulatory tracking systems for medical devices.
Role type
Regulatory Affairs Specialist
Builds
Medical device product lines and marketing materials
Domain
Medical Devices / Regulatory Compliance
Required skills
Regulatory assessment, global regulatory expertise, product lifecycle knowledge, regulatory terminology, pre-market submission types, impact evaluation, project planning
Preferred skills
Multi-tasking, ability to work under pressure
Technologies
None stated
Responsibilities
Perform regulatory assessments for proposed product changes and supplier requests, review product literature and marketing collateral for compliance, collaborate on regulatory plans for line extensions, monitor tracking and control systems, stay abreast of regulatory procedures and industry developments
Seniority
Mid-level, hands-on IC