Regulatory Affairs Manager

3 weeks ago


Bedford, United States Genabio Diagnostics Full time

Qualifications:


  • degree or above in a relevant discipline required
  • years of industrial experience in IVD or medical device FDA registration
  • in Chinese preferred


Tasks:

  • and support new product 510k Submissions
  • and support International Device Licensing and Registrations
  • product development teams with new product submission requirements
  • guidance on worldwide regulatory requirements for medical devices and external government product audits by FDA and other inspection agencies as needed
  • and support the implementation of clinical research projects
  • and support clinical sites management through all phases of the clinical trial
  • to clinical sites during the qualification phase and as needed to ensure sites are in compliance and regulatory and study requirements are being fulfilled
  • that documentation from clinical trial sites meets FDA/GCP/GDP requirements



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