About Us Barrington James are recruiting for a Director of Quality Assurance and Regulatory Affairs (QARA) for a fast-growing Medical Device company based in Galway, Ireland.
They are a fast-growing start-up in the medical device industry, focused on bringing cutting-edge fitness and wellness technologies to market.
As part of their mission to revolutionize health and fitness, they're looking for an experienced and visionary QARA Director to lead regulatory strategy and ensure quality compliance across all levels of their product portfolio.
Key Responsibilities Lead and manage all Quality Assurance and Regulatory Affairs activities, ensuring full compliance with FDA and other international medical device regulations. Develop and implement QA strategies to support R&D, production, and commercialization efforts. Oversee product certifications, regulatory submissions, and approvals, particularly in the U.S. (FDA) and Europe (CE marking). Provide strategic leadership and guidance to the team, ensuring high standards in quality management systems. Work closely with cross-functional teams to ensure the seamless integration of regulatory and commercial strategies. Foster a start-up mindset, promoting agility and adaptability in a rapidly evolving environment. Qualifications & Experience Proven experience in the medical device industry, specifically working with FDA regulations. Background in R&D within the medical devices space (preferred). Strong leadership skills with the ability to lead cross-functional teams. Commercially savvy, with a keen understanding of how regulatory frameworks impact business success. Based in Ireland, with flexibility for remote working. Ability to thrive in a dynamic, fast-paced start-up environment. The company offers a competitive salary, along with an attractive benefits package.
If this role is of interest, please apply or email ****** for more information.
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