Lead Specialist, Regulatory Affairs, Japan

GE HealthCare UK

Tokyo, JP
5+ years japanese medical device regulatory experience
Class ii medical device independent management
End-to-end change management and renewal processes
This role serves as a practical leader responsible for the entire product lifecycle of imaging medical devices in Japan

Job Summary

  • This role serves as a practical leader responsible for the entire product lifecycle of imaging medical devices in Japan.
  • The position involves strategic planning, managing Class II and select Class III device approvals, and handling SaMD regulatory responses.
  • Candidates will collaborate cross-functionally with R&D, QA, and global teams while leading QMS updates and acting as a Center of Excellence.

Matching Summary

Match Score: 85

This role serves as a practical leader responsible for the entire product lifecycle of imaging medical devices in Japan.

Skills & Requirements

Must-have

  • 5+ years Japanese medical device regulatory experience
  • Class II medical device independent management
  • End-to-end change management and renewal processes
  • Native Japanese proficiency for official submissions
  • Business level English for global collaboration

Nice-to-have

  • Experience with Class III medical devices
  • SaMD software medical device application experience
  • Knowledge of GVP and GMP quality systems
  • Global team collaboration experience
  • STEM background or science engineering degree

Key Requirements

  • 5+ years regulatory affairs experience in Japan
  • Independent Class II device management experience
  • Native Japanese language skills
  • Business English proficiency
  • Bachelor's degree in STEM preferred

Work Rights

Not specified

Tailored Resume

Cover Letter