Regulatory Affairs Professional

4 days ago


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

We are looking for a Regulatory Affairs Professional to support our business in the Asia Pacific region. The ideal candidate will have experience in managing regulatory submissions and obtaining medical device pre-market approvals.

Main Tasks

  • Author and manage regulatory applications required for product market approvals in the Asia Pacific region.
  • Develop and maintain Asia Pacific Technical Files in compliance with local regulatory requirements and the Accuray Quality Management System.
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements.

Qualifications

  • 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.
  • Strong analytical and problem-solving skills.

About Accuray Asia Ltd

Accuray Asia Ltd is a company that values innovation and excellence in medical devices. We strive to be a leader in the Asia Pacific region and are committed to providing high-quality products that meet regulatory requirements.



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