Director of Compliance Brightwater Executive is delighted to be retained exclusively by our client, the Health Products Regulatory Authority (HPRA) in their search for a Director of Compliance. About the Company The Health Products Regulatory Authority (HPRA) is the independent regulator of medicines, medical devices and healthcare products in Ireland. The Agency is of substantial strategic importance to both public and animal health protection. Through its regulatory role it directly contributes to better health outcomes, as well as supporting the relevant industry and broader life sciences sectors based in Ireland and across Europe. About the Position Reporting to the Chief Executive and as a key member of the Executive Leadership Team, the Director of Compliance provides strategic and operational leadership of HPRAs Compliance function. The role has responsibility for inspection, investigation, enforcement, licensing and market surveillance across a broad regulatory remit, including human and veterinary medicines, GxP systems, clinical trials, medical devices, blood, tissues and organs, controlled drugs, precursor chemicals and cosmetics. The position also leads the national framework for medicines shortages monitoring and coordination. The Director of Compliance will guide regulatory judgement and decision quality, ensuring that compliance decisions are consistent, proportionate, evidence-based and aligned with EU and national legislation and guidance. The role requires the ability to manage complex regulatory matters, exercise sound judgement in high-impact decisions and lead a large, multidisciplinary department through ongoing organisational development and change. Key Responsibilities: Provide strategic leadership of the Compliance Department, ensuring delivery of high-quality inspection, licensing, surveillance, investigation and enforcement activities aligned with HPRAs strategy and service plans. Ensure the development, implementation and consistent application of technical standards, inspection procedures, administrative processes and enforcement policies across all compliance domains. Oversee complex compliance cases, investigations and regulatory escalations, ensuring decisions comply with legislation, guidance and HPRA policy. Lead the licensing and authorisation of manufacturers, wholesalers, controlled drugs operators, precursor chemical operators and other regulated entities. Ensure effective market surveillance activities, including sampling, testing, quality defect investigations and oversight of recalls. Direct the national medicines shortages coordination function, ensuring effective information flow, risk assessment and communication with healthcare system stakeholders. Optimise departmental structure, capability and resourcing through workforce planning, performance management, succession planning and budget oversight. Lead continuous improvement initiatives, enhancing regulatory processes, quality systems, digital tools and data-driven decision-making. Represent HPRA at national, EU and international committees and regulatory networks, contributing to policy development and harmonisation of regulatory standards. Support the development, implementation and interpretation of relevant legislation, providing expert regulatory and technical advice. Build strong, collaborative relationships with government departments, health service bodies, industry stakeholders and international regulators. Experience/Requirements A relevant third-level life science qualification (NFQ Level 7 or 8). A minimum of five years relevant experience, including leading multiple teams at a senior management level, with strategic decision-making responsibility within one or more of the pharmaceutical industry, regulatory affairs, medicines regulation or the healthcare sector, with a focus on product quality. A proven record of leading and motivating multidisciplinary teams and developing high-performing organisational cultures. Strong knowledge of Irish, EU and international regulatory frameworks, legislation and standards governing medicines, medical devices, controlled drugs, blood and tissues and related health product domains. Demonstrated competence in risk management, including risk assessment, mitigation and avoidance. Proven experience contributing to regulatory policy, interpreting legislation and representing an organisation with senior stakeholders and decision-makers. Exceptional analytical and problem-solving capability, with sound judgement and the ability to manage complex and sensitive regulatory issues. Excellent communication, influencing and stakeholder-management skills, with the ability to represent HPRA nationally and internationally. High levels of integrity, resilience and professional accountability, aligned with HPRAs commitment to public health protection. In addition, the ideal candidate will have: A postgraduate qualification (NFQ Level 9 or 10) in a relevant field. Experience in the implementation of EU legislation and guidelines. Experience dealing with the media. Remuneration Package Salary: €143,930 per annum Contact For further information on this Director of Compliance opportunity, please contact Yvonne McNulty at Brightwater Executive and we can send you a full job description. To apply applicants should submit a CV and a cover letter addressing the key responsibilities and qualifications. The closing date for applications is 19th January at 5pm. Skills: Team Leadership Healthcare Regulatory Affairs Medicine Quality Management Product Management Risk Management