Healthcare Industry Regulatory Affairs Manager

3 days ago


Hong Kong Island, Hong Kong SAR China Accuray Asia Ltd Full time
Role Summary:

This Regulatory Affairs Specialist role supports the development and implementation of regulatory strategies to ensure market access for Accuray products and services in Asia Pacific.

Key Responsibilities:

  • Develop and maintain relationships with regulatory authorities and industry stakeholders.
  • Provide regulatory guidance and support to cross-functional teams.
  • Author and submit regulatory documents, including technical files and marketing authorization applications.
  • Maintain up-to-date knowledge of relevant regulatory requirements and standards.
Qualifications:

A Bachelor's Degree in a technical discipline, such as Engineering, Bio-medical Engineering, Computer Science, Physics, Biology, or Chemistry, is required.

A minimum of 3 years' experience in Regulatory Affairs, preferably in medical devices, is required.

Strong knowledge of Asia Pacific regulations and standards applicable to medical device market clearance is essential.

Proven track record of clearing medical devices to market in Asia Pacific countries is preferred.

Excellent verbal and written English and Chinese communication skills, strong attention to detail, and excellent organizational skills are essential.



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