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. * Translating regulatory and normative changes into actionable quality and compliance requirements - 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. * Acting as escalation point for regulatory, compliance and release-related risks and decisions * 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
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