Specialist, Commercial Quality & Regulatory Affairs
Danaher · Taipei City, Taiwan
RegulatoryFull-timeCompany career page
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Role summary
Danaher seeks a Specialist for Commercial Quality & Regulatory Affairs in Taipei to ensure diagnostic products comply with Taiwan and Hong Kong regulations. The role involves managing regulatory submissions, supporting quality system execution, coordinating with health authorities, and collaborating across functions to maintain market approvals and operational compliance.
What they're looking for
- Bachelor's degree in Science, Pharmacy, Engineering, or related field
- 3+ years experience in regulatory affairs or quality, or Master's degree with 2 years experience
- Knowledge of ISO 13485 Quality Systems and Regulatory Affairs principles
- Demonstrated regulatory or scientific knowledge in medical device or IVD industry in Taiwan or Hong Kong
- Strong technical writing, attention to detail, and project management skills
What you'll be doing
- Support quality and regulatory activities including investigations, deviations, complaints, and corrective actions
- Support regulatory submissions, filings, renewals, and post-approval changes for commercial products
- Support health authority interactions, audits, and inspections
- Maintain regulatory files, track obligations, and ensure current information in regulatory databases
- Collaborate with cross-functional teams on quality processes and regulatory responsibilities
Privacy & handoff
This role links to Danaher's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.