Specialist, Regulatory Affairs

Danaher UK

Beijing, China
Not specified (likely office-based given the context).
Nmpa regulation expertise
Ivd product registration
Regulatory compliance support
Danaher UK is seeking a Specialist in Regulatory Affairs for their Beijing office, focusing on product registration and compliance in the IVD industry. The ideal candidate will possess a relevant educational background, at least two years of RA experience, and strong communication skills in both English and Chinese

Job Summary

  • This position is responsible for submitting product registration dossiers and obtaining approvals in compliance with regulations and SOPs across China, US, EU, and other target markets.
  • The role involves maintaining strong relationships with regulatory authorities such as NMPA and affiliated organizations, as well as providing regulatory support to internal teams and external customers.
  • Danaher offers a collaborative environment where employees contribute to accelerating the real-life impact of tomorrow’s science and technology by solving complex challenges globally.

Matching Summary

Match Score: 85

Danaher UK is seeking a Specialist in Regulatory Affairs for their Beijing office, focusing on product registration and compliance in the IVD industry. The ideal candidate will possess a relevant educational background, at least two years of RA experience, and strong communication skills in both English and Chinese.

Skills & Requirements

Must-have

  • NMPA regulation expertise
  • IVD product registration
  • regulatory compliance support
  • cross-functional team collaboration
  • product registration dossier submission
  • regulation update interpretation

Nice-to-have

  • excellent teamwork skills
  • positive attitude and responsibility
  • creative problem solving
  • good interpersonal communication

Key Requirements

  • Bachelor degree or above
  • 2+ years RA experience in IVD industry
  • China MD and IVD registration experience preferred
  • Good English and Chinese language skills

Work Rights

Not specified

Tailored Resume

Cover Letter