Principal Regulatory Affairs Specialist - Mervue

Medtronic

Mervue, Ireland
Base: 81,360.00 eur - 122,040.00 eur; bonus/equity...
Regulatory submissions preparation
Eu mdr and fda compliance
Cross-functional collaboration
This role entails implementing regulatory strategies, managing regulatory submissions, assessing the regulatory impact of product changes, and ensuring your team delivers high-quality results through providing guidance and mentorship to team members

Job Summary

  • This role entails implementing regulatory strategies, managing regulatory submissions, assessing the regulatory impact of product changes, and ensuring your team delivers high-quality results through providing guidance and mentorship to team members.
  • Medtronic offers a competitive Salary and flexible Benefits Package designed to support employees at every career and life stage.
  • The Principal Regulatory Affairs Specialist collaborates closely with cross-functional partners such as R&D, clinical, operations, and marketing to ensure regulatory needs are integrated into product development and lifecycle management.

Matching Summary

This role entails implementing regulatory strategies, managing regulatory submissions, assessing the regulatory impact of product changes, and ensuring your team delivers high-quality results through providing guidance and mentorship to team members.

Salary

Base: 81,360.00 EUR - 122,040.00 EUR; Bonus/Equity: Eligible for Medtronic Incentive Plan (MIP); Benefits: Flexible Benefits Package

Skills & Requirements

Must-have

  • Regulatory submissions preparation
  • EU MDR and FDA compliance
  • Cross-functional collaboration
  • Medical device lifecycle management
  • Regulatory change assessments
  • Review of advertising and promotional materials

Nice-to-have

  • Mentorship and team development
  • Problem-solving and risk escalation
  • Strong technical knowledge
  • Global regulatory alignment
  • Ethical behavior and accountability

Key Requirements

  • Level 8 Honor’s Degree Science or Engineering
  • Minimum 7 years relevant experience
  • Regulatory experience with Class III Medical Devices
  • Experience with FDA and EU MDR regulations
  • Regulatory Affairs qualification desirable

Work Rights

Not specified

Tailored Resume

Cover Letter