As Regulatory & Quality Integration Manager (f/m/x), you strengthen and connect regulatory and quality capabilities across a diversified product portfolio in a dynamic global regulatory landscape. * Ensuring end-to-end compliance within complex regulatory setups (e.g. manufacturer, importer, EU Authorized Representative) * Assessing and implementing new and evolving regulatory requirements (e.g. EU AI Act, Cyber Resilience Act, EHDS) * Proven experience in cross-functional projects (e.g. product launches, localization, remediation or portfolio transitions) * Solid knowledge of relevant regulations and standards (e.g. ISO 13485, ISO 14971, IVDR) and their application across the product lifecycle within a QMS * Familiarity with complex regulatory setups (e.g. manufacturer, importer, EU Authorized Representative) and evolving frameworks (e.g. EU AI Act, Cyber Resilience Act, EHDS)
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