Senior Regulatory Affairs Specialist
$69,073–$103,598 year
Hybrid · Athlone, Leinster, Ireland
Job Summary
Senior Regulatory Affairs Specialist responsible for regulatory activities related to the Airways product portfolio within Acute Care & Monitoring; prepares regulatory submissions (CE-Mark, FDA), supports EU MDR implementation, leads regulatory documentation, develops regulatory strategies with cross-functional teams, and ensures compliant labeling, manufacturing, and clinical protocol evaluation; requires experience with medical devices, EU MDR, FDA requirements, and cross-functional collaboration; hybrid work arrangement in Ireland (Mervue, Galway and Athlone, Westmeath).
Required Qualifications
- Honor’s Degree Science or Engineering
- Bachelor’s degree/master’s with a minimum of 5 years of relevant experience, preferably with Class I & Class II Medical Devices
- Regulatory Affairs qualification is desirable, but not mandatory
- Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745
- Experience with software and hardware medical devices
- Proven ability to manage multiple projects and priorities
- Strong technical knowledge and problem-solving skills
- Ability to collaborate with global cross-functional teams
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