Asia Pacific Regulatory Compliance Expert

5 days ago


Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time

About This Role

We are looking for a highly experienced Regulatory Affairs Specialist to join our team in Asia Pacific.

This role is responsible for preparing, submitting, and managing regulatory applications required for product market approvals in Asia Pacific.

Responsibilities

  • Support obtaining medical device pre-market regulatory approvals to ensure market access for Accuray products and services.
  • Authorize and manage Asia Pacific Technical Files in compliance with local regulatory requirements.
  • Act as a Regulatory Affairs subject matter expert on new product introduction and engineering design control teams.
  • Collaborate with cross-functional teams to ensure clinical research and evaluations meet regulatory requirements.
  • Contribute to quality system and design dossier audits as a subject matter expert.
  • Compile and prepare materials for Medical Device Reports (MDR) and other regulatory decision-making processes.


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