Senior Regulatory Affairs Specialist, AP Region

5 days ago


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

We are seeking a Senior Regulatory Affairs Specialist to support obtaining medical device pre-market regulatory approvals in the Asia Pacific region. This role involves authoring regulatory submissions through third-party entities and ensuring market access for Accuray products.

Key Responsibilities

  • Prepare and submit regulatory applications required for product market approvals in the Asia Pacific region.
  • Manage Asia Pacific Technical Files in compliance with local regulatory requirements and the Accuray Quality Management System.
  • Function as a subject matter expert on new product introduction and engineering design control teams.

Requirements

  • A Bachelor's Degree in a technical discipline such as Engineering, Bio-medical Engineering, Computer Science, Physics, Biology, or Chemistry.
  • A minimum of 3 years' experience in Regulatory Affairs for medical devices, especially those containing software and electro/mechanical components.
  • Solid working knowledge and experience of Asia Pacific regulations and standards applicable to medical device market clearance.
  • Excellent verbal and written English and Chinese (Mandarin) communication skills.

About Accuray Asia Ltd

Accuray Asia Ltd is a leading manufacturer of medical devices that require regulatory approvals in the Asia Pacific region. We offer a competitive salary and benefits package to successful candidates who can join our team as a Senior Regulatory Affairs Specialist.



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