Regulatory Affairs Specialist – NMPA China (all gender)
Core
Creating and updating regulatory documentation for medical devices in China (NMPA), conducting GAP analyses between EU MDR and Chinese requirements, and leading corrective actions.
Role type
Regulatory Affairs Specialist (Medical Devices)
Builds
Regulatory submissions and technical documentation for medical devices
Domain
Medical devices / Regulatory Affairs / China market
Deliverable
client delivery
Required skills
NMPA regulatory system experience, EU MDR knowledge, Chinese GB standards knowledge, Life Sciences/Medical Technology/Pharmacy degree, structured work in international teams
Preferred skills
English fluency
Technologies
N/A
Responsibilities
Create and update regulatory documentation for medical devices in China, Conduct GAP analyses between EU MDR and Chinese requirements, Ensure compliance with Chinese GB standards, Coordinate the NMPA approval process including e-Submission and authority coordination, Work closely with local partners and international project teams
Seniority
Mid-level, hands-on IC