Regulatory Affairs Specialist, AP Region Position

3 days ago


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

Are you a detail-oriented and organized individual with a passion for Regulatory Affairs? Do you have a solid understanding of Asia Pacific regulations and standards applicable to medical devices?

Accuray Asia Ltd is seeking a Regulatory Affairs Specialist to support the Asia Pacific Region in obtaining medical device pre-market regulatory approvals.

This role requires strong analytical and problem-solving skills, as well as excellent communication and interpersonal skills.

We offer a dynamic and supportive work environment, and we encourage applicants who are passionate about Regulatory Affairs to apply.

Responsibilities:

  • Prepare and submit regulatory applications for product market approvals
  • Manage Asia Pacific Technical Files in compliance with local regulatory requirements
  • Ensure compliance with Accuray Quality Management System
  • Function as a Regulatory Affairs subject matter expert on new product introduction and engineering design control teams
  • Assist research personnel and risk management specialists to ensure clinical research and clinical evaluations are performed in accordance with necessary regulatory requirements
  • Gather and prepare materials for Medical Device Reports (MDR), Vigilance, Adverse Events, Recall, etc.

Qualifications:

  • 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
  • Strong knowledge of Asia Pacific regulations and standards applicable to medical devices
  • Proven track record clearing medical devices to market in Asia Pacific countries
  • Proficiency in working through third parties to obtain market clearance


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