Regulatory Specialist – Medical Device Start-Up | GalwayTricardia 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 DoPrepare and support 510(k) and CE Mark submissionsMaintain Technical Documentation in line with MDRManage regulatory database filings (FURLS, EUDAMED)Provide regulatory input on design changes, labelling, IFUs, and marketing materialsSupport complaint investigations, PMS/vigilance activities, and external auditsRepresent Regulatory Affairs on project teams and help develop internal proceduresWhat You'll BringDegree in Engineering or Science2+ years' experience in medical devicesUnderstanding of FDA and/or MDR requirementsStrong technical and analytical skillsExcellent communication and writing abilityExperience in start-up/SME environments preferredHands-on, proactive, and committed to continuous learningWhy Join?Inclusive, supportive team cultureHigh visibility and influence in a growing organisationOpportunity to help advance technology that can change stroke treatment worldwideIf you want to make a meaningful impact while growing your regulatory career, this is an excellent opportunity.