Lead Specialist, Regulatory Affairs, Japan

GE HealthCare UK

Hino, Japan
On-site
Medical device regulatory strategy
Class ii medical device submissions
Change control and renewal processes
GE HealthCare Japan is seeking a Lead Specialist in Regulatory Affairs for medical devices, primarily focusing on Class II and some Class III products. The ideal candidate will have extensive experience in regulatory practices within the Japanese market, particularly in managing product lifecycle and cross-functional collaboration

Job Summary

  • Lead regulatory affairs for imaging and other medical devices in the Japanese market, focusing on Class II and some Class III devices.
  • Engage in regulatory strategy development, submission management, change control, and liaison with regulatory authorities like PMDA.
  • Collaborate with R&D, QA, Safety, and Global RA teams, and review promotional materials and safety information.

Matching Summary

Match Score: 85

GE HealthCare Japan is seeking a Lead Specialist in Regulatory Affairs for medical devices, primarily focusing on Class II and some Class III products. The ideal candidate will have extensive experience in regulatory practices within the Japanese market, particularly in managing product lifecycle and cross-functional collaboration.

Skills & Requirements

Must-have

  • Medical device regulatory strategy
  • Class II medical device submissions
  • Change control and renewal processes
  • SaMD regulatory compliance
  • Cross-functional team collaboration
  • Regulatory authority liaison

Nice-to-have

  • Class III medical device experience
  • PMDA approval project involvement
  • Device equipment regulatory knowledge
  • QA/Safety knowledge (GVP/GMP)
  • Global team collaboration experience

Key Requirements

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

Work Rights

Not specified

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