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 highly skilled Regulatory Affairs Specialist to support the approval of medical devices in the Asia Pacific region. This individual will be responsible for preparing and submitting regulatory applications to ensure market access for our products.

The ideal candidate will have experience with Asia Pacific regulations and standards applicable to medical device market clearance. They should also be proficient in working through third parties to obtain market clearance in the region.

This position reports to the Director of Accuray Regulatory and Quality, Asia Pacific Region, and is located in Hong Kong.

Responsibilities:
  • Prepare, submit, and manage regulatory applications required for product market approvals in Asia Pacific Region.
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
  • Develop and maintain knowledge of Asia Pacific regulations and standards.
  • Manage post-market agency reporting activities such as Recall and Correction & Removal Reporting.
Requirements:
  • Bachelor's Degree in a technical discipline such as Engineering, Bio-medical Engineering, Computer Science, Physics, Biology, or Chemistry.
  • Minimum of 3 years' experience in Regulatory Affairs in medical devices, especially products containing software and electro/mechanical components.
  • Solid working knowledge and experience of the Asia Pacific regulations and standards applicable to medical device market clearance.
  • Proven track record clearing medical devices to market in Asia Pacific countries including but not limited to Korea, Singapore, Malaysia, Thailand, Australia, Taiwan, and Hong Kong.


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