Lead Specialist, Regulatory Affairs, Japan

GE Healthcare

Hino, Japan
Medical device regulatory affairs
Class ii medical device submissions
Change control and update processes
Lead regulatory affairs for imaging and other medical devices (Class II/some Class III) in the Japanese market

Job Summary

  • Lead regulatory affairs for imaging and other medical devices (Class II/some Class III) in the Japanese market.
  • Engage in strategic planning, submission processes, change management, and cross-functional collaboration with R&D, QA, and global teams.
  • This role offers the opportunity to gain experience in growing fields like SaMD and digital health, acting as a subject matter expert.

Matching Summary

Lead regulatory affairs for imaging and other medical devices (Class II/some Class III) in the Japanese market.

Skills & Requirements

Must-have

  • Medical device regulatory affairs
  • Class II medical device submissions
  • Change control and update processes
  • Cross-functional team collaboration
  • Regulatory authority interaction

Nice-to-have

  • Proactive problem-solving
  • Driving initiatives
  • Balancing hands-on and leadership
  • Embracing new regulatory areas

Key Requirements

  • 5+ years of regulatory affairs experience in Japan
  • Experience with Class II medical devices
  • End-to-end change control/update experience
  • Native level Japanese
  • Business level English

Work Rights

Not specified

Tailored Resume

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