Regulatory Affairs Specialist, Asia Pacific Market Access

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 to support obtaining medical device pre-market regulatory approvals and ensure market access for our products in the Asia Pacific region.

This role involves authoring regulatory submissions through third-party entities, staying vigilant of developing standards and regulations, and their impact on product clearances. The candidate must handle post-market agency reporting activities such as Recall and Correction & Removal Reporting.

Responsibilities

  • Prepare, submit, and manage regulatory applications required for product market approvals in Asia Pacific.
  • Author and manage Asia Pacific Technical Files in compliance with local regulatory requirements and our 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 clinical evaluations align with necessary regulatory requirements.
  • Participate in internal and external quality system and design dossier audits as a subject matter expert.
  • Gather and prepare materials to facilitate decision-making process for Medical Device Reports (MDR), Vigilance, Adverse Events, Recall, etc.
  • Compile and prepare all materials, reports, and follow-up with Regulatory Agencies regarding recall activity.
  • Prepare documentation and reports after interpreting Asia Pacific countries regulations for submission to other units of the company, customers, governmental regulatory agencies, etc.


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