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.
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.