Position:Business Project Manager – QA (Regulatory & Digital Transformation)Location:Athenry, Ireland and HybridExperience:8+ years (with strong QA/Regulatory project management background)Domain:Medical Device / Life Sciences / Regulated ManufacturingJob Summary:We are seeking aBusiness Project Manager (QA – Regulatory)to lead initiatives focused on enhancing Quality Management Systems (QMS) and driving digital transformation within regulated manufacturing environments. The ideal candidate will have strong experience in Quality Assurance, regulatory compliance (FDA, ISO 13485, EU MDR), and digital systems integration (MES, ERP, eQMS).Key Responsibilities:Quality & Regulatory ManagementMaintain and continuously improve the Quality Management System (QMS) in alignment with ISO 13485, FDA regulations, and other global standards.Ensure compliance with applicable regulatory requirements (FDA, EU MDR, ISO, 21 CFR Part 11).Support preparation for and participation in internal and external audits (FDA, Notified Bodies).Oversee documentation and management of CAPAs, SCARs, deviations, and non-conformances .Digital Transformation & System IntegrationIntegrate quality controls into automated, data-driven manufacturing and digital workflows .Collaborate with IT, Manufacturing, and QA teams to embed quality assurance into MES (Manufacturing Execution Systems) and ERP systems .Monitor and validate data integrity across digital platforms used in production and quality control.Lead or support IQ/OQ/PQ validation activities for new digital equipment and software systems.Review and approve validation protocols, change controls, and technical documentation .Data, Analytics & ComplianceEnsure audit readiness and compliance of digital systems and electronic records.Conduct periodic trending analysis of quality metrics and digital system performance.Support predictive analytics and AI-based quality monitoring initiatives.Provide guidance on data governance, cybersecurity, and digital traceability .Training & CollaborationTrain cross-functional teams on QMS procedures, regulatory requirements, and use of digital QA tools .Collaborate with engineering, manufacturing, and IT to ensure compliance and quality integration in all digital initiatives.Preferred Experience & Skills:Proven experience in Quality Assurance or Project Management within regulated industries (medical device, life sciences, pharma, or manufacturing).Strong understanding of ISO 13485, FDA QSR, EU MDR, and 21 CFR Part 11 compliance.Experience managing routers/Bill of Materials (BOMs) and digital manufacturing transitions.Hands-on experience with electronic DHR/DHR management and presenting during audits.Knowledge of software validation, electronic records compliance, and digital QMS systems .Experience leading cross-functional digital transformation projects in a regulated setting.Excellent communication, stakeholder management, and documentation skills.Education & Certification:Bachelor's or Master's degree in Engineering, Life Sciences, Quality, or related field.PMP, Six Sigma, or Quality Management certifications (CQE, CQA) preferred