Regulatory Affairs Specialist, Asia Pacific

1 week ago


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

Job Description

We are seeking a highly skilled Regulatory Affairs Specialist, AP Region to support the obtaining of medical device pre-market regulatory approvals and ensure market access for Accuray products and services in Asia Pacific.

This role involves authoring regulatory submissions through third-party entities and monitoring developing standards and regulations impacting product clearances. Additionally, the successful candidate will handle post-market agency reporting activities such as Recall and Correction & Removal Reporting.

Main Responsibilities

  • Prepare and submit regulatory applications required for product market approvals in Asia Pacific Region.
  • Author and manage 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.
  • Collaborate with research personnel, application specialists, and risk management specialists to ensure clinical research and evaluations meet necessary regulatory requirements.
  • Participate in quality system and design dossier audits as a subject matter expert.
  • Gather materials for Medical Device Reports (MDR), Vigilance, Adverse Events, Recall decision-making process.
  • Compile reports and communicate with Regulatory Agencies regarding recall activity.


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