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Job ID :
47921BR
Location :
China - Beijing
:
Job Description

Key Responsibilities:

  • 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


Qualifications Required:

  • 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


Desired:

  • IVD and MD registration experiences.
  • Clinical diagnosis major or work experiences.
  • Skilled in Excel and other Microsoft Office


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