Associate Regulatory Operations Specialist - Japanese Speaker

Medtronic UK

Competitive salary; short-term incentive (mip); fl...
Not specified (further details needed)
Japanese language proficiency jlpt n3 or higher
Bachelor's degree in medical/biological science/engineering
Experience with e-ctd submissions and document management
Medtronic UK is seeking an Associate Regulatory Operations Specialist who is proficient in both Japanese and English, with at least one year of relevant experience. The role involves preparing and managing regulatory submissions for medical devices or pharmaceuticals, emphasizing attention to detail and effective communication

Job Summary

  • The role involves preparing, publishing, and ensuring quality control for regulatory submissions including initial marketing authorization applications and electronic common technical documents.
  • Medtronic offers a competitive salary, flexible benefits package, and eligibility for the Medtronic Incentive Plan (MIP) to support employees at every career stage.
  • Employees will lead with purpose by breaking down barriers to innovation while championing healthcare access and equity for all.

Matching Summary

Match Score: 85

Medtronic UK is seeking an Associate Regulatory Operations Specialist who is proficient in both Japanese and English, with at least one year of relevant experience. The role involves preparing and managing regulatory submissions for medical devices or pharmaceuticals, emphasizing attention to detail and effective communication.

Salary

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

Skills & Requirements

Must-have

  • Japanese language proficiency JLPT N3 or higher
  • Bachelor's degree in Medical/Biological Science/Engineering
  • Experience with e-CTD submissions and document management
  • DMAIC methodology understanding
  • Proficiency in MS Office Excel VLOOKUP and DocuSign

Nice-to-have

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

Key Requirements

  • Minimum 1 year job experience in similar role
  • Business level English communication skills
  • Scientific knowledge to understand technical documents

Work Rights

Not specified

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