AP Region Regulatory Affairs Expert

1 week ago


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

About the Role

The Regulatory Affairs Specialist, AP Region will play a crucial role in ensuring the timely clearance of medical devices in Asia Pacific countries. This includes preparing and submitting regulatory applications, managing technical files, and collaborating with cross-functional teams.

The ideal candidate will possess a strong understanding of Asia Pacific regulations and standards applicable to medical device market clearance. They will also be proficient in working through third parties to obtain market clearance in Asia Pacific countries.

Main Requirements

  • Bachelor's Degree in a technical discipline such as Engineering, Bio-medical Engineering, Computer Science, Physics, Biology, or Chemistry.
  • Minimum 3 years' experience in Regulatory Affairs, especially in medical devices containing software and electro/mechanical components.
  • Solid knowledge and experience of Asia Pacific regulations and standards applicable to medical device market clearance.
  • Proven track record clearing medical devices to market in Asia Pacific countries, including Korea, Singapore, Malaysia, Thailand, Australia, Taiwan, and Hong Kong.
  • Excellent verbal and written communication skills in English and Chinese (Mandarin).


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