Regulatory Affairs Lead Asia Pacific

6 days ago


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

As a Regulatory Affairs Lead in Asia Pacific, you will play a critical role in ensuring market access for Accuray products and services in the region. Your primary responsibilities will include preparing and submitting regulatory applications, managing technical files, and collaborating with cross-functional teams to achieve business objectives.

To succeed in this role, you will need to have a strong understanding of Asia Pacific regulations and standards applicable to medical devices, as well as experience in clearing medical devices to market in countries such as Korea, Singapore, Malaysia, Thailand, Australia, Taiwan, and Hong Kong. Proficiency in working through third parties to obtain market clearance is also essential.

  • Key Responsibilities
  • Prepare and submit regulatory applications for medical device market approvals in Asia Pacific Region
  • Manage Asia Pacific Technical Files in compliance with local regulatory requirements and the Accuray Quality Management System
  • Collaborate with cross-functional teams to ensure market access for Accuray products and services in Asia Pacific

Required Skills and Qualifications

  • Bachelor's Degree in a technical discipline such as Engineering, Bio-medical Engineering, Computer Science, Physics, Biology, or Chemistry
  • Minimum of 3 years' Regulatory Affairs experience 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


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