Sr Regulatory Affairs Spec

Medtronic UK

Competitive salary; short-term incentive plan (mip...
5+ years medical device regulatory experience
Class ii electrical medical device certification
Class iii post-market or improved device approval
The role involves leading the strategy and execution of manufacturing approvals and maintenance for surgical robots, AI digital technologies, and electrosurgical products

Job Summary

  • The role involves leading the strategy and execution of manufacturing approvals and maintenance for surgical robots, AI digital technologies, and electrosurgical products.
  • Candidates must possess strong logical thinking and problem-solving abilities to handle diverse tasks including document creation, administrative inquiries, and change management.
  • Medtronic offers a comprehensive benefits package including up to 360,000 JPY in child-rearing support, mentorship programs, and stock purchase plans.

Matching Summary

The role involves leading the strategy and execution of manufacturing approvals and maintenance for surgical robots, AI digital technologies, and electrosurgical products.

Salary

Competitive Salary; Short-term incentive plan (MIP) available; Benefits include child-rearing subsidy up to 360,000 JPY

Skills & Requirements

Must-have

  • 5+ years medical device regulatory experience
  • Class II electrical medical device certification
  • Class III post-market or improved device approval
  • Japanese and English business communication skills
  • Strategy formulation for regulatory submissions

Nice-to-have

  • Experience working with overseas counterparts
  • Knowledge of AI in medical devices
  • Understanding of electrical and materials engineering
  • Experience with product design and quality management
  • Willingness to travel internationally

Key Requirements

  • 5+ years of medical device regulatory application experience
  • Experience with Class II electrical medical device certification
  • Experience with Class III post-market or improved device approval
  • Fluency in Japanese and English for technical documentation
  • Strong communication and negotiation skills

Work Rights

Not specified

Tailored Resume

Cover Letter