Asia Pacific Regulatory Affairs Expert

4 days ago


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

We are looking for an experienced Regulatory Affairs Specialist, Asia Pacific Region to join our team at Accuray Asia Ltd.

The primary responsibility of this role is to support obtaining medical device pre-market regulatory approvals to ensure market access for Accuray products and services in Asia Pacific.

The key areas of focus for this position include:

  • Preparation, submission, and management of regulatory applications required for product market approvals in Asia Pacific Region.
  • Maintenance of Asia Pacific Technical Files in compliance with local regulatory requirements and the Accuray Quality Management System.
  • Serving as a Regulatory Affairs subject matter expert on new product introduction and engineering design control teams.

The successful candidate will have excellent verbal and written communication skills in English and Chinese (Mandarin), with a strong attention to detail and excellent organizational skills.



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