Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist Location: Gort, Co. Galway (Hybrid – 2–3 days onsite per week)Function: Quality Assurance & RegulatoryReports to: Regulatory Affairs Manager   Overview We are seeking a Senior Regulatory Affairs Specialist to join our team in Gort, Co. Galway. This is a key role responsible for leading and coordinating global regulatory submissions across new and established products, ensuring full compliance with regional and international regulatory requirements. This position offers the opportunity to work cross-functionally in a dynamic, patient-focused environment while contributing to strategic regulatory planning and execution.   Key Responsibilities Lead the preparation, coordination, and submission of regulatory documentation for global product registrations, renewals, and variations Ensure compliance with EU MDR/IVDR, FDA, and other applicable regulatory requirements Develop and implement regulatory strategies to support timely product approvals and market access Review and recommend changes to labelling, manufacturing processes, clinical protocols, and marketing materials Act as a key liaison with regulatory authorities, managing communications and submissions on defined matters Monitor evolving regulatory requirements and ensure organisational readiness and compliance Drive improvements in regulatory tracking systems, processes, and controls Provide technical leadership across cross-functional project teams Translate complex regulatory requirements into clear guidance for non-specialist stakeholders Mentor junior team members and support capability development within the team Contribute to audit and inspection readiness (internal and external)   About You 5–8+ years’ experience in Regulatory Affairs within the medical device, pharmaceutical, or life sciences sector Strong working knowledge of EU MDR and/or FDA regulations Proven experience managing complex regulatory submissions and cross-functional projects Demonstrated ability to influence stakeholders and drive alignment on regulatory strategies Excellent communication skills, with the ability to simplify complex technical topics Strong organisational and project management capability Proactive, solutions-focused mindset with the ability to anticipate risks and challenges   What You’ll Bring Deep regulatory expertise with a strategic outlook Experience leading or contributing to large-scale, cross-functional initiatives A collaborative approach aligned to a patient-first culture High levels of accountability, agility, and teamwork   Why Join Us? Competitive salary package with pension. Health Insurance & Life Assurance coverage. Educational Assistance Program. Employee Rewards Program. Excellent career progression opportunities. Influence supplier strategy and long-term quality outcomes Join an innovative organization shaping the future of neurodiagnostic and healthcare technology. Work in a collaborative environment with strong opportunities for career development and professional growth. Take full ownership of strategically critical categories with real business impact. Be part of a collaborative, high-performing sourcing function shaping future capability.