About this role
<div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Your Role</b></H2> </div><div><div>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. You ensure effective integration of requirements across the full product lifecycle, enabling compliance, market access and efficient implementation in cross-functional environments. </div> <div>Your key responsibilities include: </div> <div> <ul> <li>Driving alignment of regulatory and quality requirements across the full product lifecycle, from development through post-market activities </li> <li>Ensuring end-to-end compliance within complex regulatory setups (e.g. manufacturer, importer, EU Authorized Representative) </li> <li>Supporting project execution by implementing regulatory and quality requirements in product launches, localization and portfolio initiatives </li> <li>Providing regulatory and quality input to lifecycle activities such as design changes, market expansions and product updates </li> <li>Ensuring structured, controlled and compliant technical documentation within the quality management system </li> <li>Assessing and implementing new and evolving regulatory requirements (e.g. EU AI Act, Cyber Resilience Act, EHDS) </li> <li>Identifying regulatory and quality risks or compliance gaps and driving pragmatic, sustainable solutions </li> <li>Collaborating with cross-functional stakeholders to ensure consistent and integrated regulatory and quality approaches </li> <li>Promoting efficient and harmonized processes across regulatory, quality and product-related activities </li> </ul> </div></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Your Profile</b></H2> </div><div><div>You are a strong match if you combine solid experience in regulatory affairs and quality management with a pragmatic, solution-oriented mindset and the ability to drive cross-functional collaboration in complex environments.</div> <div>Ideally, you bring the following qualifications and strengths: </div> <div> <ul> <li>Degree in Life Sciences, Engineering, Regulatory Affairs or a comparable field </li> <li>5+ years of professional experience in medical devices or IVD, with exposure to Regulatory Affairs and Quality Management </li> <li>Proven experience in cross-functional projects (e.g. product launches, localization, remediation or portfolio transitions) </li> <li>Solid knowledge of relevant regulations and standards (e.g. ISO 13485, ISO 14971, IVDR) and their application across the product lifecycle within a QMS </li> <li>Familiarity with complex regulatory setups (e.g. manufacturer, importer, EU Authorized Representative) and evolving frameworks (e.g. EU AI Act, Cyber Resilience Act, EHDS) </li> <li>Strong analytical and problem-solving skills with a structured, proactive and solution-oriented working style </li> <li>Excellent stakeholder management and communication skills in international environments </li> <li>Fluent in English; German language skills are a plus</li> </ul> </div></div></div></div>