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RA Spec I

Bio-Rad · Taipei, Taipei, Taiwan

Location
Taipei
Job Type
Full-time
Posted
June 03, 2026

Job Description

Responsible for managing product registrations for the assigned product line, including new registrations, renewals, and registration changes. In addition, the role supports compliance with applicable Quality Management System requirements and TFDA Good Distribution Practice requirements for the Taiwan branch

How You’ll Make an Impact:

  • manage product registrations in accordance with established plans and maintain RAQA

  • handle and oversee the TFDA regulatory submissions, including new applications, renewals, and change submissions.

  • handle the field action activities and post‑market surveillance in compliance with local regulations and global requirements.

  • handle the implementation and maintenance of Quality Management System processes at the Taiwan branch.

  • liaise with divisional Regulatory Affairs, Quality Assurance teams, and local functional teams.

  • Communicate directly with relevant regulatory authorit...

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