Regulatory Affairs Manager

3 hours ago

Galway, Ireland Life Science Recruitment Ltd Full time

Regulatory Affairs Manager Our client a fast-growing medical device company based in the West of Ireland, dedicated to transforming outcomes for patients are seeking a highly motivated Regulatory Affairs Manager to lead and oversee all regulatory compliance activities. This critical leadership role will define and execute regulatory strategies in support of both new product development and post-market activities. Role/Responsibilities Lead the regulatory strategy for new product introductions and support existing products through their full lifecycle. Manage regulatory submissions (e.g. 510(k), CE Mark) and global product registrations. Act as the primary contact for regulatory agencies, including authorities in the U.S. and Europe. Monitor and interpret evolving regulatory requirements and apply them to ensure company compliance. Partner with Quality Assurance to ensure post-market surveillance and vigilance activities meet applicable standards. Review and approve promotional and advertising materials from a regulatory perspective. Identify and allocate internal and external resources needed to maintain a robust regulatory function. Provide strategic advice and cross-functional support on all regulatory matters. Candidate Requirements Bachelors degree in Engineering, Life Sciences, or a health-related field. 10+ years of experience in the medical device industry, with a minimum of 3 years in a leadership or management role. In-depth knowledge of US FDA and EU medical device regulations (including MDR). Proven ability to handle complex regulatory submissions and interactions. Excellent organizational, leadership, and communication skills. A self-starter with a hands-on approach and the ability to thrive in a dynamic, entrepreneurial environment. Previous experience in an SME or medtech startup is highly desirable. For further information please contact James Cassidy or call in confidence

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