Sr RA Specialist, APAC Indirect Mkts
Core
Execute regulatory strategy for obtaining registration approval of medical devices in APAC indirect markets.
Role type
Senior Regulatory Affairs Specialist
Builds
Regulatory submissions and documentation for medical device registrations
Domain
Medical Devices / Healthcare
Required skills
Regulatory strategy execution, regulatory documentation compilation, change management, regulatory compliance, regulatory surveillance, impact assessment, regulatory database management
Preferred skills
Experience with Agile, Veeva, TrackWise, regulatory information management systems
Technologies
Veeva, PRDb, Agile, Smartsheet, TrackWise
Responsibilities
Coordinate with Distributor RA to compile regulatory documentation, evaluate medical device changes and execute regulatory strategy, communicate with stakeholders to ensure compliance, input and manage regulatory submission tracking information, compile high quality submissions, perform periodic regulatory surveillance and impact assessments
Seniority
Senior, hands-on IC