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Medical Device Market Access Professional

2 weeks ago

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

Job Overview

Accuray Asia Ltd. seeks an experienced Regulatory Affairs Specialist to support the approval process for medical devices in Asia Pacific.

The successful candidate will be responsible for preparing and submitting regulatory applications, managing technical files, and collaborating with internal teams to ensure regulatory compliance.

Key Tasks

  • Manage regulatory applications for product market approvals in Asia Pacific.
  • Develop and maintain knowledge of Asia Pacific regulations and standards applicable to medical devices.
  • Collaborate with research personnel to ensure clinical research meets regulatory requirements.
  • Participate in quality system and design dossier audits as a subject matter expert.
  • Compile and prepare materials for regulatory decision-making processes.