Job ID :
China - Beijing
- Work out IVD and MD product registration plan and conduct effectively.
- Communicate with CFDA and prompt registration going smoothly.
- Own CFDA registration sample test in China
- Review registration technical dossier and guide overseas RA providing documents as CFDA requirements.
- Training to commercial associations on China regulations.
- Other project support when needed within RA team
- BS or higher in healthcare field, major in clinical medicine or pharmacy is prioritized.
- A minimum of 2 years experiences in medical devices industry, at least 1 year in IVD/MD registration.
- Understand CFDA regulation requirements on MD/IVD registration.
- Good communication skill cross function and cultures.
- Fluency in English
- IVD and MD registration experiences.
- Clinical diagnosis major or work experiences.
- Skilled in Excel and other Microsoft Office