This range is provided by TRICARDIA. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay rangeDirect message the job poster from TRICARDIASenior Director of Regulatory Affairs - Breakthrough Stroke TherapyLocation: Galway, Ireland (Hybrid/Onsite)We’re partnering with a growth-stage medical device company developing a cutting-edge catheter-based platform to transform the treatment of acute ischemic stroke. Following successful clinical trials and key regulatory approvals, the company is now entering the early stages of commercialisation.About the Role:This is a senior leadership position requiring 15+ years of experience in the medical device industry, including at least 7 years in a leadership capacity. You will define and execute global regulatory strategies, lead 510(k) and CE Mark submissions, act as the PRRC under MDR, and guide risk management and design assurance functions. You’ll also be the key liaison with regulatory bodies including the FDA and Notified Bodies.Key Requirements:15+ years’ experience in medical devices (Class II/III ideally), with strong US and EU regulatory expertiseDemonstrated success in leading regulatory functions within a start-up or SME environmentStrategic mindset with a hands-on, adaptable approachStrong leadership and communication skills, with the ability to guide cross-functional teams through global submissions and compliance activitiesSeniority levelSeniority levelDirectorEmployment typeEmployment typeFull-timeJob functionJob functionOtherIndustriesMedical Equipment ManufacturingReferrals increase your chances of interviewing at TRICARDIA by 2xGet notified about new Director of Regulatory Affairs jobs in Galway, County Galway, Ireland.We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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