RA Specialist
Core
Execute regulatory strategy for obtaining registration approval of medical devices in APAC indirect markets.
Role type
Regulatory Affairs Specialist (Medical Devices)
Builds
Regulatory submissions and documentation for medical device registrations
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
client delivery
Required skills
Medical device registration, regulatory strategy execution, compliance management, change management, license maintenance, regulatory surveillance, impact assessment, database management, stakeholder coordination
Preferred skills
Regulatory information management systems (Agile, Veeva, TrackWise)
Technologies
Veeva, PRDb, Agile, Smartsheet, TrackWise
Responsibilities
Coordinate regulatory documentation for submission to authorities, evaluate medical device changes and execute strategies, manage regulatory submission tracking, perform periodic regulatory surveillance and impact assessments, compile high-quality submissions meeting technical requirements
Seniority
Mid-Senior, hands-on IC