Prin Quality Systems Spec

Medtronic

Japan
Competitive salary; short-term incentive via medtr...
Iso 13485 knowledge
Japanese medical regulations compliance
Global security policy implementation
This role serves as a Principal Specialist in the quality systems domain, ensuring alignment between global policies and Japanese domestic laws regarding medical information systems

Job Summary

  • This role serves as a Principal Specialist in the quality systems domain, ensuring alignment between global policies and Japanese domestic laws regarding medical information systems.
  • The incumbent will lead security reviews for cloud and remote services, manage audit responses, and develop educational content to enhance employee security awareness.
  • Medtronic offers a competitive salary, flexible benefits package, and eligibility for the Medtronic Incentive Plan (MIP) to support employees at every career stage.

Matching Summary

This role serves as a Principal Specialist in the quality systems domain, ensuring alignment between global policies and Japanese domestic laws regarding medical information systems.

Salary

Competitive Salary; Short-term incentive via Medtronic Incentive Plan (MIP); Flexible Benefits Package

Skills & Requirements

Must-have

  • ISO 13485 knowledge
  • Japanese medical regulations compliance
  • Global security policy implementation
  • System security review experience
  • Audit and evidence preparation

Nice-to-have

  • ISO 27001 Lead Implementor certification
  • Internal audit experience
  • Project management expertise
  • Mentoring junior specialists
  • Stakeholder negotiation skills

Key Requirements

  • Bachelor's degree with 7+ years experience or Master's with 5+ years
  • Deep understanding of ISO 13485 and QSR regulations
  • Desirable ISO 27001 implementation experience or certification

Work Rights

Not specified

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