Regulatory Affairs Specialist (cs @ Tokyo)

Medtronic UK

Tokyo, Japan
On-site
Medical device regulatory affairs
Communication with overseas manufacturers
English communication and technical reading
Medtronic UK is seeking a Regulatory Affairs Specialist in Tokyo, Japan, to facilitate the timely introduction of medical devices to the Japanese market. The ideal candidate will have experience in regulatory submissions and a strong understanding of relevant laws, with proficiency in both Japanese and English

Job Summary

  • Act as a bridge to deliver meaningful medical devices to Japanese patients.
  • Formulate application strategies for regulatory approval and insurance coverage in collaboration with overseas manufacturers and relevant departments.
  • Medtronic offers a competitive salary and flexible benefits package, recognizing employee contributions and supporting them at every career and life stage.

Matching Summary

Match Score: 85

Medtronic UK is seeking a Regulatory Affairs Specialist in Tokyo, Japan, to facilitate the timely introduction of medical devices to the Japanese market. The ideal candidate will have experience in regulatory submissions and a strong understanding of relevant laws, with proficiency in both Japanese and English.

Skills & Requirements

Must-have

  • Medical device regulatory affairs
  • Communication with overseas manufacturers
  • English communication and technical reading
  • Understanding of PMDA regulations
  • Ability to create high-quality applications
  • Collaboration with domestic departments

Nice-to-have

  • Experience with Class IV medical devices
  • Project management skills
  • Logical thinking ability
  • Learning ability for product knowledge

Key Requirements

  • Bachelor's degree or equivalent
  • Experience in medical device regulatory affairs
  • English proficiency for communication and technical reading
  • Basic understanding of Japanese pharmaceutical and medical device laws
  • Excellent Japanese and English writing skills
  • Multitasking and coordination skills
  • Project management skills
  • Logical thinking skills
  • Communication and negotiation skills
  • Experience working with overseas counterparts
  • General PC skills (Word, Excel, PowerPoint)
  • Learning ability for product knowledge

Work Rights

Not specified

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