Regulatory Specialist – Medical Device Start-Up | Galway
Tricardia is working with a fast‑growing Galway-based medtech company that has developed breakthrough catheter‑based technology to improve outcomes for Acute Ischemic Stroke patients. Following positive pivotal trial data, they’re on the verge of commercialisation and are hiring a Regulatory Specialist to support regulatory submissions and ensure successful market access.
Base pay range
Direct message the job poster from TRICARDIA
What You’ll Do
* Prepare and support 510(k) and CE Mark submissions
* Maintain Technical Documentation in line with MDR
* Manage regulatory database filings (FURLS, EUDAMED)
* Provide regulatory input on design changes, labelling, IFUs, and marketing materials
* Support complaint investigations, PMS/vigilance activities, and external audits
* Represent Regulatory Affairs on project teams and help develop internal procedures
What You’ll Bring
* Degree in Engineering or Science
* 2+ years’ experience in medical devices
* Understanding of FDA and/or MDR requirements
* Strong technical and analytical skills
* Excellent communication and writing ability
* Experience in start‑up/SME environments preferred
* Hands‑on, proactive, and committed to continuous learning
Why Join?
* Inclusive, supportive team culture
* High visibility and influence in a growing organisation
* Opportunity to help advance technology that can change stroke treatment worldwide
If you want to make a meaningful impact while growing your regulatory career, this is an excellent opportunity.
Seniority level
Associate
Employment type
Full‑time
Job function
Other
Industries
Medical Equipment Manufacturing
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