Not specified (assumed office-based with potential for limited travel)
2 years ra working experience in ivd industry
Expertise in nmpa regulation of medical devices
Bachelor degree in medicine or bioengineering
Danaher Corp is seeking a Specialist in Regulatory Affairs to manage product registration and ensure compliance with regulations across various markets, including China, the US, and Europe. The ideal candidate will have a relevant educational background and at least two years of experience in the IVD industry, particularly with NMPA regulations
Job Summary
This position is responsible for submitting product registration dossiers and obtaining approval according to the registration plan while ensuring compliance with regulations.
The incumbent will execute product registration strategy plans across China, US, EU, and other target markets for IVD products.
The role requires establishing and maintaining good relationships with key contacts such as type testing centers and NMPA officials.
Matching Summary
Match Score: 85
Danaher Corp is seeking a Specialist in Regulatory Affairs to manage product registration and ensure compliance with regulations across various markets, including China, the US, and Europe. The ideal candidate will have a relevant educational background and at least two years of experience in the IVD industry, particularly with NMPA regulations.
Skills & Requirements
Must-have
2 years RA working experience in IVD industry
Expertise in NMPA regulation of medical devices
Bachelor degree in medicine or bioengineering
Nice-to-have
Good English and Chinese language skills
Creative thinking for complex registration cases
Positive attitude and teamwork skills
Key Requirements
2+ years Regulatory Affairs experience in IVD
China MD and IVD registration experience preferred
Bachelor degree in Medicine, Bioengineering, or Pharmacy