Principal Regulatory Affairs Specialist - Mervue

MEDTRONIC

Mervue, Ireland
Irel + : 81,360.00 eur - 122,040.00 eur; bonus/equ...
Regulatory strategy implementation
Regulatory submission management
Product change impact assessment
Implement regulatory strategies, manage submissions, assess product change impacts, and mentor team members to ensure high-quality results

Job Summary

  • Implement regulatory strategies, manage submissions, assess product change impacts, and mentor team members to ensure high-quality results.
  • Collaborate with R&D, clinical, operations, and marketing to integrate regulatory needs into product development and lifecycle management.
  • Medtronic offers a competitive salary and flexible benefits package, recognizing employee contributions and sharing in their success.

Matching Summary

Implement regulatory strategies, manage submissions, assess product change impacts, and mentor team members to ensure high-quality results.

Salary

Ireland: 81,360.00 EUR - 122,040.00 EUR; Bonus/Equity: MIP eligible; Benefits: Flexible Benefits Package

Skills & Requirements

Must-have

  • Regulatory strategy implementation
  • Regulatory submission management
  • Product change impact assessment
  • Cross-functional collaboration
  • EU MDR implementation support
  • Medical device lifecycle management

Nice-to-have

  • Dynamic team player
  • Critical thinking and decision making
  • Ethical behavior modeling
  • Attention to detail
  • Results oriented

Key Requirements

  • Minimum 7 years relevant experience
  • Class III Medical Devices experience
  • Medical Devices regulatory experience
  • FDA regulatory requirements experience
  • EU MDR experience
  • International regulatory agency requirements experience

Work Rights

Not specified

Tailored Resume

Cover Letter