Associate Regulatory Operations Specialist - Japanese Speaker

MEDTRONIC

Competitive salary; short-term incentive mip avail...
Not specified
Japanese language proficiency jlpt n3 or higher
Bachelor's degree in medical or biological science
Experience with regulatory submission systems
Medtronic is seeking an Associate Regulatory Operations Specialist who is a Japanese speaker, responsible for preparing and managing regulatory submissions. The ideal candidate will possess a Bachelor's degree in a relevant field and have experience in regulatory operations, with strong communication skills in both Japanese and English

Job Summary

  • The role involves preparing, publishing, and quality controlling paper and electronic components for marketing authorization applications and e-CTDs.
  • Medtronic offers a competitive salary, flexible benefits package, and eligibility for the Medtronic Incentive Plan (MIP).
  • Candidates must possess strong communication skills in both English and Japanese to handle regulatory correspondence and documentation.

Matching Summary

Match Score: 85

Medtronic is seeking an Associate Regulatory Operations Specialist who is a Japanese speaker, responsible for preparing and managing regulatory submissions. The ideal candidate will possess a Bachelor's degree in a relevant field and have experience in regulatory operations, with strong communication skills in both Japanese and English.

Salary

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

Skills & Requirements

Must-have

  • Japanese language proficiency JLPT N3 or higher
  • Bachelor's degree in Medical or biological science
  • Experience with regulatory submission systems
  • Proficiency in MS Office Excel V lookups
  • Knowledge of DMAIC methodology

Nice-to-have

  • Background in Japanese Medical Device Regulation
  • Experience with GTS Insight RDR Ariba Polaris Readsoft
  • Ability to read technical test reports and raw data
  • Vendor evaluation and process improvement skills

Key Requirements

  • Bachelor's Degree in Medical/biological science/Engineering
  • Minimum 1 year job experience in similar role
  • JLPT N3 level or up Japanese certification
  • Business level English reading writing and speaking

Work Rights

Not specified

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