Regulatory Compliance Expert for Medical Devices

2 weeks ago


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

We are seeking a highly skilled Regulatory Compliance Expert for Medical Devices to join our team at Accuray Asia Ltd. In this role, you will be responsible for ensuring that our medical devices comply with all relevant regulatory requirements in the Asia Pacific region.

Key Responsibilities:
  • Conducting regulatory reviews to ensure compliance with local regulations and standards.
  • Preparing and submitting regulatory documents to regulatory authorities in a timely manner.
  • Collaborating with internal stakeholders to ensure that all necessary documentation is prepared and submitted to regulatory authorities.
  • 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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