Asia Pacific Region Regulatory Affairs Manager

2 weeks ago


Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time
About the Role:

This is an exciting opportunity to join our team at Accuray Asia Ltd as a Asia Pacific Region Regulatory Affairs Manager. In this role, you will be responsible for managing regulatory submissions and ensuring compliance with local regulatory requirements in the Asia Pacific region.

Responsibilities Include:
  • Preparing and submitting regulatory applications required for product market approvals in the Asia Pacific Region.
  • Authoring and managing Asia Pacific Technical Files in compliance with local regulatory requirements and our quality management system.
  • Coordinating with internal stakeholders to ensure that all necessary documentation is prepared and submitted to regulatory authorities in a timely manner.
  • Providing guidance and support to colleagues on regulatory matters related to medical devices.

Requirements:
  • A 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 in medical devices, especially products containing software and electro/mechanical components.
  • Solid working 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 but not limited to Korea, Singapore, Malaysia, Thailand, Australia, Taiwan, and Hong Kong.
  • Proficiency in working through third parties to obtain market clearance in Asia Pacific countries.
  • Excellent verbal and written English and Chinese (Mandarin) communication skills; strong attention to detail and excellent organizational skills.


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