Medical Device Clearance Professional

2 days ago


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

This Regulatory Affairs Specialist position supports the obtaining of medical device pre-market regulatory approvals, ensuring market access for Accuray products and services in Asia Pacific.

Key Responsibilities:

  • Prepare, submit, and manage regulatory applications for product market approvals in Asia Pacific.
  • Author Asia Pacific Technical Files in compliance with local regulatory requirements and the Accuray Quality Management System.
  • Function as a Regulatory Affairs subject matter expert on new product introduction and engineering design control teams.
  • Assist research personnel, application specialists, and risk management specialists to ensure clinical research and clinical evaluations comply with necessary regulatory requirements.
  • Participate in internal and external quality system and design dossier audits as a subject matter expert.
Requirements:

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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