Regulatory Affairs Specialist
Core
Performs regulatory assessments for product changes and line extensions, reviews marketing collateral for compliance, and monitors tracking systems for Class II medical devices.
Role type
Regulatory Affairs Specialist
Builds
Regulatory compliance for medical device product lifecycle changes
Domain
Medical Devices / Regulatory Affairs
Required skills
Regulatory assessment, Global regulatory expertise, Product lifecycle knowledge, Regulatory terminology, Pre-market submission knowledge, Impact evaluation
Preferred skills
Multi-tasking, Project planning, Deadline management
Technologies
None stated
Responsibilities
Perform regulatory assessments for proposed product changes and supplier requests, Review product literature and marketing collateral for compliance, Collaborate on plans for line extensions, Monitor tracking and control systems, Stay abreast of regulatory procedures and industry developments
Seniority
Mid-level, 2+ years experience