Principal Officer, Regulatory Affairs

Danaher UK

Suzhou, China
Nmpa regulation of ivd
Product registration dossier submission
Cdx registration strategy plans
Submit product registration dossier and get approval according to the registration plan, with compliance to regulations and SOP

Job Summary

  • Submit product registration dossier and get approval according to the registration plan, with compliance to regulations and SOP.
  • Establish and execute CDx registration strategy plans in China/US/EU/Other target markets.
  • Follow up and interpret Global MD, IVD & CDx related regulation updates.

Matching Summary

Submit product registration dossier and get approval according to the registration plan, with compliance to regulations and SOP.

Skills & Requirements

Must-have

  • NMPA regulation of IVD
  • product registration dossier submission
  • CDx registration strategy plans
  • Global MD, IVD & CDx regulation updates
  • GMP / ISO 13485 quality system

Nice-to-have

  • creative thinking for complexed cases
  • positive thinking & take responsibility
  • good attitude

Key Requirements

  • 5 years or above RA working experience
  • IVD industry experience
  • China CDx initial registration experience
  • US/EU IVD registration experience
  • Bachelor degree or above

Work Rights

Not specified

Tailored Resume

Cover Letter