Company Information and Introduction:Diploma Lifesciences Ireland and UK comprises three leading companies: Accuscience Ireland Ltd., Technopath Distribution Ltd., and Electramed Ltd.Our purpose is simple yet powerful: we make a difference in people's lives. As specialised, value-adding distribution businesses, we supply essential products and services across the Healthcare, Pharma, Life Sciences, and Food sectors in Ireland and the UK. Our focus spans three key areas—Medical, In Vitro Diagnostics (IVD), and Scientific—where we deliver innovative solutions to hospitals, laboratories, community care providers, and scientific industries.Together, we form Diploma Lifesciences Ireland and UK, part of the Lifesciences Sector of Diploma PLC, a FTSE 100 company. This gives us the unique advantage of combining local agility with global strength. With over 135 dedicated team members, we are building a purpose-led, values-driven culture that fosters high performance, inclusivity, and career development.We are proud to be accredited as Investors in Diversity Bronze by the Irish Centre for Diversity—recognising our ongoing commitment to creating inclusive workplaces where everyone feels valued, respected, and empowered to thrive.Key Responsibilities and Duties: Job PurposeThe Quality and Regulatory Affairs Manager (QARM) will lead all Quality and Regulatory activities across Technopath Distribution Ltd and Accuscience Ireland Ltd. This role ensures compliance with international standards, regulatory requirements, and health and safety legislation, while driving continuous improvement across supply chain and distribution processes.Key Duties and ResponsibilitiesQuality Management System (QMS)Develop, implement, and maintain the Integrated Management System (IMS) across both businesses.Ensure compliance with ISO 9001, ISO 13485, ISO 27001 certifications and ISO 17025 accreditation.Integrate QMS processes across sites to streamline operations and maintain consistency.Conduct internal audits and coordinate external audits, ensuring timely closure of findings.Manage corrective and preventive actions (CAPAs) and lead CAPA teams.Oversee document control and change control processes.Validate new equipment and materials, including training and monitoring.Regulatory AffairsEnsure compliance with MDR/IVDR, GDP guidelines, and applicable health regulations.Manage product registration and regulatory submissions via EUDAMED and MHRA.Monitor regulatory changes and update internal policies accordingly.Act as primary liaison with regulatory authorities and notified bodies.Prepare and maintain technical documentation for regulatory compliance.Health & SafetyAct as Safety Officer, ensuring compliance with company Safety Statement and Risk Assessments.Help provide health and safety training with external consultants and ensure protective equipment is available.Monitor workplace safety and implement risk mitigation measures.Supplier & Customer QualityManage supplier onboarding, qualification, and performance monitoring.Ensure supplier compliance with quality standards and resolve quality issues promptly.Review product specifications and disposition decisions (acceptance/rejection).Build strong relationships with customers on quality and regulatory matters.Information SecurityImplement and maintain ISO 27001 standards for information security.Ensure confidentiality, integrity, and availability of information assets.Leadership & Continuous ImprovementLead and develop the Quality & Regulatory team, providing coaching and feedback.Drive continuous improvement initiatives across quality and compliance processes.Monitor KPIs and report progress to senior management.Support implementation of new systems (e.g., ERP) to enhance compliance and efficiency.Key Skills and Competencies:Degree in Science, Quality Management, or related discipline.Minimum 5 years' experience in Quality Assurance and Regulatory Affairs within healthcare, medical devices, or pharmaceutical sectors.Strong knowledge of ISO standards, MDR/IVDR, and GDP guidelines.Proven experience in audits, CAPA management, and risk assessment.Excellent leadership, communication, and stakeholder management skills.