Lead Regulatory Affairs Specialist, Japan

GE HealthCare

Fully remote
Regulatory strategy and direction
Healthcare regulatory requirements
Product launch and submissions
GE HealthCare is seeking a Lead Regulatory Affairs Specialist for Japan, responsible for overseeing regulatory strategy and compliance for product launches, submissions, and post-market activities. The role requires strong knowledge of regulatory frameworks and experience in regulatory affairs, with a focus on collaboration and communication within a remote work environment

Job Summary

  • Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally.
  • Lead Specialist, Regulatory Affairs is responsible for all RA tasks of own modality with supervision by the direct manager or project leader.
  • This role involves working closely with healthcare regulatory bodies and industry association and requires an in-depth understanding of key business drivers to accomplish work effectively.

Matching Summary

Match Score: 85

GE HealthCare is seeking a Lead Regulatory Affairs Specialist for Japan, responsible for overseeing regulatory strategy and compliance for product launches, submissions, and post-market activities. The role requires strong knowledge of regulatory frameworks and experience in regulatory affairs, with a focus on collaboration and communication within a remote work environment.

Skills & Requirements

Must-have

  • Regulatory strategy and direction
  • Healthcare regulatory requirements
  • Product launch and submissions
  • Postmarket compliance
  • Advanced Japanese language skill
  • Business level English

Nice-to-have

  • QA/Safety Management experience
  • Proactive communication in remote environment
  • Sharing mind and coaching skills
  • Flexibility to adapt to different processes and cultures

Key Requirements

  • Minimum of 5 years experience as an independent Regulatory Affairs professional
  • Advanced level Japanese language skill
  • Business level English (writing, reading, speaking)
  • Proven interpersonal skills
  • Professional judgment and ability to operate with some autonomy

Work Rights

Not specified

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