Medical Device Clearance Specialist

6 days ago


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

This is an exciting opportunity for a motivated Regulatory Affairs Specialist to join our team at Accuray Asia Ltd. As a key member of the Regulatory and Quality team, you will play a critical role in ensuring compliance with Asia Pacific regulations and standards for medical devices.

Responsibilities
  • Support obtaining medical device pre-market regulatory approvals in Asia Pacific.
  • Collaborate with internal stakeholders to ensure compliance with regulatory requirements.
  • Participate in internal and external quality system audits.

Requirements
  • Bachelor's Degree in a technical discipline such as Engineering, Bio-medical Engineering, Computer Science, Physics, Biology, or Chemistry.
  • Minimum 3 years' Regulatory Affairs experience in medical devices, especially products containing software and electro/mechanical components.
  • Excellent verbal and written English and Chinese communication skills.


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