Senior Product Regulator Officer / Product Regulatory Manager – Medical Device

Posted 1 month ago

Requirement

  • Degree holder in medical Engineering
  • 3-5 year in Regulatory in medical device in Trading or Factory
  • Good knowledge in ISO 13485, ISO9001, 510K, CE, CMDCAS, CFDA legislation.
  • Proficient of English and Mandarin

     Duties:

  • Handle regulatory affairs, such as product license registration/renewal, coordinating customers/internal audits, preparing of ISO documentations and etc.
  • Comply with ISO 13485.
  • Conduct training for staff to fulfill the regulatory requirements. 
  • Good knowledge in ISO 13485, ISO9001, 510K, CE, CMDCAS/MDSAP, CFDA / NMPA legislation.

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