Principal Officer, Regulatory Affairs

Danaher

Suzhou, China
Nmpa ivd/medical device regulation
Cdx registration strategy
Global regulatory updates interpretation
Submit product registration dossiers and achieve approval according to the registration plan, ensuring compliance with regulations and SOPs

Job Summary

  • Submit product registration dossiers and achieve approval according to the registration plan, ensuring compliance with regulations and SOPs.
  • Establish and execute CDx registration strategy plans in China, US, EU, and other target markets, while participating in product development and co-development projects with Pharma Partners.
  • Follow up and interpret global MD, IVD & CDx related regulation updates, and provide regulatory support to cross-functional teams, dealers, and customers.

Matching Summary

Submit product registration dossiers and achieve approval according to the registration plan, ensuring compliance with regulations and SOPs.

Skills & Requirements

Must-have

  • NMPA IVD/medical device regulation
  • CDx registration strategy
  • Global regulatory updates interpretation
  • GMP/ISO 13485 quality system support
  • Establish NMPA relationships

Nice-to-have

  • Creative thinking for complex cases
  • Positive attitude and responsibility
  • Teamwork and interpersonal communication

Key Requirements

  • 5 years or above RA working experience in IVD
  • China CDx initial registration experiences
  • US/EU IVD registration experiences
  • Bachelor degree or above

Work Rights

Not specified

Tailored Resume

Cover Letter