Regulatory Affairs Specialist (cs @ Tokyo)

Medtronic Diabetes

Tokyo, Japan
Competitive salary; short-term incentive (mip) ava...
Not specified (assumed hybrid based on industry norms)
Medical device regulatory submission experience
Class iv medical device application knowledge
English communication and technical reading skills
Medtronic Diabetes is seeking a Regulatory Affairs Specialist for their Tokyo office, aiming to facilitate the timely introduction of medical devices to Japanese patients. The ideal candidate should possess a strong background in regulatory submissions, particularly for Class IV medical devices, along with excellent communication skills in both Japanese and English

Job Summary

  • The main mission is to act as a bridge to deliver meaningful medical devices to Japanese patients.
  • Responsibilities include developing regulatory approval strategies, preparing high-quality applications, and coordinating with domestic and international departments.
  • Medtronic offers a competitive salary, flexible benefits package, and eligibility for the Medtronic Incentive Plan.

Matching Summary

Match Score: 85

Medtronic Diabetes is seeking a Regulatory Affairs Specialist for their Tokyo office, aiming to facilitate the timely introduction of medical devices to Japanese patients. The ideal candidate should possess a strong background in regulatory submissions, particularly for Class IV medical devices, along with excellent communication skills in both Japanese and English.

Salary

Competitive Salary; Short-term incentive (MIP) available; Flexible Benefits Package

Skills & Requirements

Must-have

  • Medical device regulatory submission experience
  • Class IV medical device application knowledge
  • English communication and technical reading skills
  • Understanding of Pharmaceutical Affairs Law
  • Project management and multitasking abilities

Nice-to-have

  • Experience with overseas manufacturers
  • Strong logical thinking and negotiation skills
  • Ability to learn product knowledge quickly

Key Requirements

  • Bachelor's degree or equivalent qualification
  • Experience in Class IV medical device regulatory submissions preferred
  • Proficiency in Japanese and English business communication

Work Rights

Not specified

Tailored Resume

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