Senior Specialist, Commercial Quality And Regulatory Affairs
Danaher
Taipei, Taiwan
On-site
Medical device regulatory compliance
Ivd registration strategy
Taiwan and hong kong regulations
Danaher is seeking a Senior Specialist in Commercial Quality and Regulatory Affairs to join their team in Taipei, Taiwan. The role focuses on ensuring compliance with local medical device regulations and collaborating with cross-functional teams to drive regulatory strategies and quality assurance efforts
Job Summary
The role involves interpreting country regulations for Danaher Dx products in Taiwan and Hong Kong to ensure compliance with MD/IVD standards.
Candidates will be responsible for preparing, reviewing, and submitting regulatory documentation for product registrations, renewals, and changes to local authorities.
Danaher offers comprehensive benefit programs including healthcare and paid time off to support a culture of belonging and continuous improvement.
Matching Summary
Match Score: 85
Danaher is seeking a Senior Specialist in Commercial Quality and Regulatory Affairs to join their team in Taipei, Taiwan. The role focuses on ensuring compliance with local medical device regulations and collaborating with cross-functional teams to drive regulatory strategies and quality assurance efforts.
Skills & Requirements
Must-have
Medical device regulatory compliance
IVD registration strategy
Taiwan and Hong Kong regulations
Commercial operations QMS execution
Local authority submission preparation
Nice-to-have
Global IVD regulations knowledge
CE-IVDR experience
ISO13485 implementation background
Cross-functional collaboration skills
Continuous improvement mindset
Key Requirements
Master's degree with 5+ years experience or Bachelor's with 7+ years
Demonstrated knowledge of medical device or IVD industry in Taiwan/Hong Kong
Experience interpreting complex regulatory requirements for commercial operations