Principal Regulatory Affairs Specialist - Mervue

Medtronic Diabetes

Mervue, Ireland
Base: 86,720.00 eur - 130,080.00 eur; bonus/equity...
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7 years medical device regulatory experience
Eu mdr and fda regulatory requirements knowledge
Class iii medical device submission expertise
** Medtronic Diabetes is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategies and submissions for medical devices, particularly focusing on the DAR™ Breathing System. The ideal candidate will have extensive experience in regulatory affairs within the medical device sector and a strong background in collaborating with cross-functional teams to ensure compliance and successful product development. **

Job Summary

  • This role entails implementing regulatory strategies and managing submissions for the DAR Breathing System product within the Acute Care unit.
  • The position requires translating regulatory requirements into project specifications while collaborating with global cross-functional teams to ensure timely execution.
  • Medtronic offers a competitive salary ranging from 86,720.00 EUR to 130,080.00 EUR along with a flexible benefits package and short-term incentive plan.

Matching Summary

Match Score: 75

** Medtronic Diabetes is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategies and submissions for medical devices, particularly focusing on the DAR™ Breathing System. The ideal candidate will have extensive experience in regulatory affairs within the medical device sector and a strong background in collaborating with cross-functional teams to ensure compliance and successful product development. **

Salary

Base: 86,720.00 EUR - 130,080.00 EUR; Bonus/Equity: Eligible for Medtronic Incentive Plan (MIP); Benefits: Flexible Benefits Package

Skills & Requirements

Must-have

  • 7 years medical device regulatory experience
  • EU MDR and FDA regulatory requirements knowledge
  • Class III medical device submission expertise
  • Design control documentation review skills
  • Cross-functional collaboration with R&D teams

Nice-to-have

  • Regulatory Affairs qualification preferred
  • Experience with software and hardware devices
  • Mentorship and team leadership capabilities
  • Strong critical thinking and problem-solving
  • Ethical behavior and high accountability standards

Key Requirements

  • Level 8 Honor's Degree in Science or Engineering
  • Minimum 7 years relevant regulatory experience
  • Experience with Class III Medical Devices
  • Knowledge of Regulation (EU) 2017/745
  • Work authorization status not specified

Work Rights

Not specified

Tailored Resume

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