Regulatory Affairs Specialist, Asia Pacific Region

6 days ago


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

Job Description

We are seeking a skilled Regulatory Affairs Specialist to support the obtainment of medical device pre-market regulatory approvals for Accuray products and services in Asia Pacific.

The ideal candidate will author regulatory submissions in Asia Pacific through third-party entities and ensure vigilance regarding developing standards and regulations affecting Accuray product clearances.

Key Responsibilities

  • Prepare and manage regulatory applications for product market approvals in Asia Pacific.
  • Author and submit Asia Pacific Technical Files in compliance with local regulatory requirements and the Accuray Quality Management System.
  • Provide Regulatory Affairs expertise on new product introduction and engineering design control teams.
  • Collaborate with research personnel and application specialists to ensure clinical research and evaluations meet necessary regulatory requirements.
  • Participate as a subject matter expert in quality system and design dossier audits.
  • Gather materials for Medical Device Reports (MDR), Vigilance, Adverse Events, Recall decision-making processes.
  • Prepare documentation and reports after interpreting Asia Pacific countries' regulations.


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