As Regulatory & Quality Compliance Manager – Software (f/m/x), you act as the independent governance authority for regulatory compliance, quality systems and software lifecycle conformity across Sysmex' regulated software portfolio. You ensure audit readiness, regulatory compliance, and continuous post-market oversight within the EMEA MedTech environment, while enabling compliant and efficient software development and release processes. * Ensuring compliance with applicable medical device software regulations and standards, including ISO 13485, ISO 14971, IEC 62304, IEC 62366 and IVDR * Defining, maintaining, and governing software-related quality policies, procedures, SOPs, templates and lifecycle frameworks * Acting as governance authority for software verification, validation and traceability across agile and hybrid development models
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