Sr Regulatory Affairs Spec

Medtronic

Tokyo, Japan
Medical device regulatory affairs experience
Class ii electrical medical device certification
Class iii medical device approval
Our team's main mission is to be a bridge delivering cutting-edge, valuable medical devices to patients

Job Summary

  • Our team's main mission is to be a bridge delivering cutting-edge, valuable medical devices to patients.
  • Responsibilities include obtaining manufacturing and sales approval, maintaining existing products, and developing approval strategies.
  • Medtronic offers a comprehensive benefits and compensation program designed to enhance employees' financial, physical, and mental well-being.

Matching Summary

Our team's main mission is to be a bridge delivering cutting-edge, valuable medical devices to patients.

Skills & Requirements

Must-have

  • Medical device regulatory affairs experience
  • Class II electrical medical device certification
  • Class III medical device approval
  • Japanese and English language proficiency
  • Business level English communication

Nice-to-have

  • Experience with overseas counterparts
  • Experience with overseas business trips
  • AI knowledge
  • Scientific foundational knowledge
  • Medical device design and quality control basics

Key Requirements

  • 5+ years of medical device regulatory affairs experience
  • Class II electrical medical device and disposable product certification experience
  • Class III or higher electrical medical device approval experience for generic/improved medical devices

Work Rights

Not specified

Tailored Resume

Cover Letter