Head – Quality

Job Description : Head – Quality & Regulatory Affairs (IVD) IRELAND Open to International candidates ? 25+ years of experience in Quality Assurance & Regulatory Affairs within IVD manufacturing ? Strong exposure to ISO 13485, MDSAP, CE-IVD/IVDR, WHO Prequalification (PQ), GMP, and ISO 14971 ? Proven experience handling regulatory audits, certifications, and product registrations ? Experience with rapid diagnostic tests (RDTs), lateral flow assays, and diagnostic performance validation ? Leadership experience managing cross-functional teams and driving a quality-first culture ???? Key Responsibilities • Lead Quality Management Systems (QMS) across manufacturing, R&D, and supply chain functions • Manage regulatory compliance across African and international markets • Drive audit readiness, CAPA, risk management, supplier quality, and post-market surveillance • Interface with regulatory authorities, notified bodies, and certification agencies • Build and mentor high-performing quality and regulatory teams ???? Preferred Profile • Bachelor's Degree in Biotechnology, Biochemistry, Biomedical Engineering, or related Life Sciences discipline • ISO 13485 Lead Auditor certification preferred • Exposure to WHO PQ, MDSAP, CE-IVD/IVDR, and African regulatory frameworks is highly desirable

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