Position: Product Manager + QA (Regulatory) Location:Athenry (Galway), IrelandPosition Type:ContractAre you passionate about driving quality and compliance in a digital manufacturing environment? We're looking for aProduct Manager + QA (Regulatory)professional to support our transformation toward data-driven, automated, and compliant operations.Key Responsibilities:Maintain and enhance the Quality Management System (QMS) in alignment with ISO 13485 and FDA regulations .Ensure compliance with FDA, EU MDR, and ISO standards across all processes.Integrate quality assurance into digital workflows, MES, and ERP systems .Monitor and validate data integrity across digital platforms used in production and quality control.Lead or support IQ/OQ/PQ activities for new digital equipment and software systems.Review and approve validation protocols, technical documentation, and change controls .Manage documentation for CAPAs, SCARs, and non-conformances .Prepare for and participate in FDA and Notified Body audits .Conduct trending analyses of quality metrics and digital system performance.Provide training on regulatory requirements, QMS procedures, and digital tools.Offer guidance on data governance, cybersecurity, and digital traceability in regulated environments.Preferred Skills & Experience:Proven experience in managing routers/Bill of Materials (BOMs) and manufacturing transitions to digital platforms.Hands-on experience with DHR/eDHR management via MES systems .Audit experience presenting on electronic DHR .Strong knowledge of software validation and 21 CFR Part 11 compliance.Familiarity with predictive analytics and AI tools for quality monitoring.ProductManager #QualityAssurance #RegulatoryCompliance #ISO13485 #FDACFR21Part11 #EUMDR #QualityManagementSystem #QMS #DigitalTransformation #ManufacturingJobs #MedicalDevices #MES #ERP #ValidationEngineer #DataIntegrity #SoftwareValidation #LifeSciencesJobs #QualityEngineer #PharmaJobs #AIinManufacturing #IrelandJobs #GalwayJobs #ContractJobs #NowHiring #JoinOurTeam