Associate Regulatory Operations Specialist - Japanese Speaker

Medtronic Diabetes

Competitive salary; short-term incentive (mip) ava...
Not specified
Bachelor's degree in medical/biological science/engineering
Japanese language proficiency jlpt n3 or higher
English business communication skills
Medtronic Diabetes is seeking an Associate Regulatory Operations Specialist who is a Japanese speaker and has experience in regulatory submissions. The role involves the preparation and quality control of both paper and electronic submissions, alongside responsibilities for regulatory management systems and process improvements

Job Summary

  • The role involves preparing, publishing, and quality controlling paper and electronic regulatory submissions including initial marketing authorization applications.
  • Medtronic offers a competitive salary, flexible benefits package, and eligibility for the Medtronic Incentive Plan (MIP).
  • Employees are expected to champion healthcare access and equity while breaking down barriers to innovation in a connected world.

Matching Summary

Match Score: 85

Medtronic Diabetes is seeking an Associate Regulatory Operations Specialist who is a Japanese speaker and has experience in regulatory submissions. The role involves the preparation and quality control of both paper and electronic submissions, alongside responsibilities for regulatory management systems and process improvements.

Salary

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

Skills & Requirements

Must-have

  • Bachelor's Degree in Medical/Biological Science/Engineering
  • Japanese language proficiency JLPT N3 or higher
  • English business communication skills
  • Experience with regulatory submissions and e-CTD
  • Knowledge of DMAIC methodology for process improvement
  • Proficiency in MS Office Excel VLOOKUP and document systems

Nice-to-have

  • Background in Japanese Medical Device Regulation
  • Experience with GTS/Insight/RDR/Ariba/Polaris/Readsoft systems
  • Ability to read technical documents like test reports and drawings
  • Vendor management and evaluation experience

Key Requirements

  • Minimum 1 year job experience in similar regulatory role
  • JLPT N3 level or up Japanese certification required
  • Business level English reading, writing, and speaking
  • Bachelor's degree in relevant scientific or engineering field

Work Rights

Not specified

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