1. Good understanding of our products' registration plan, including new registration, renewal and change current registration.
2. Execute the plan by quarter/month/week/day. Regularly track the implementation of the tasks and update to Corporate.
3. Maintain good communication with related bureau, ensuring smooth registration review and approval.
4. Cordinate and mange demo system for registration, ensure the system is imported and returned in time.
5. Compile the registration dossier per most updated NMPA requirements.
6. Handle reviewers questions and provide supporting documents per request.
7. Work with registration agent to ensure a structure communication is going through.
8. Support post market action, eg, audit, inspection and recall, and other routine work eg, labeling.
9. Be responsible for tracking, collecting, and documenting the policies, regulations and timely update the database to Corporate transparently.
10. Investigate and report adverse events to NMPA
11. Be in contact with test labs


Fluent in English both speaking and writing.
Bachelor degree or above, prefereably a major in medical, biomedical, mechanical or electro engineering.
Have a basic sense on registration pathway, classification, timeline and review preferences.
Have at least 3 years related working experience. Familiar with NMPA process, ISO13485, MDR, GB9706 or other standards.
A team player
Can communicate transparently and clearly
Be good at project management, ensure tasks are accomplished efficiently and timely
Works structured and are good at keeping track of multiple projects and complex processes
Pro-active