Overview In this role you drive quality and regulatory strategy for connected health products from concept to post-market. You own risk management, software quality and cybersecurity compliance across the product lifecycle. You translate evolving tech and regulatory expectations into practical processes for engineering, clinical ops and cross-functional partners. You’ll bridge fast-moving development with healthcare quality requirements and collaborate with auditors, suppliers and stakeholders. Based in Switzerland with flexible remote work up to three days per week, you help bring safe, connected care to patients worldwide. Leistungen / Benefits flexible remote work up to three days per week inclusive and diverse culture opportunity for personal development and career advancement global team collaboration focus on patient safety and impact Verantwortungsbereiche Lead quality and regulatory strategy for connected health products across the lifecycle Own risk management, software quality and cybersecurity compliance Translate evolving technology and regulatory expectations into actionable processes Close gaps between rapid technology development and healthcare quality rules Collaborate across digital health, cybersecurity, data privacy, manufacturing quality, clinical evaluation and post-market activities Support design controls, technical documentation and clinical evaluation/investigation for international markets Build trusted relationships with auditors, notified bodies, external partners and suppliers; influence decisions without direct authority Engage with cross-functional teams and external stakeholders to ensure compliance and quality objectives Communicate in English to auditors and senior stakeholders Zentrale Anforderungen 10+ years in medical device quality and regulatory affairs, including connected or software-driven products Strong knowledge of QMS, risk management, software lifecycle processes, usability and post-market surveillance Hands-on expertise in medical device cybersecurity and data privacy, including threat modelling and security risk management Experience with design controls, technical documentation and clinical evaluation for international markets Experience with digital health applications or software as a medical device; electronic drug delivery systems and manufacturing quality is a plus Ability to translate complex regulatory expectations into workable processes and communicate with auditors and senior stakeholders in English Experience managing external partners and suppliers, including technical agreements and oversight of outsourced development and manufacturing Curiosity about new technologies, collaborative by nature, and energized by protecting patients; AI in healthcare a plus collaborative by nature confident communicator with auditors and stakeholders curiosity about new technologies quality management systems (QMS) risk management software lifecycle processes
Senior Expert Integrated Health Quality Lead (all genders) Arbeitgeber: Merck
Als Arbeitgeber in Dresden bieten wir Ihnen die Möglichkeit, Teil eines innovativen Teams zu werden, das sich leidenschaftlich für Wissenschaft und Technologie einsetzt. Unsere Unternehmenskultur fördert Vielfalt und Inklusion, während wir Ihnen zahlreiche Möglichkeiten zur beruflichen Weiterentwicklung und persönlichem Wachstum bieten. Mit einem starken Fokus auf Qualität und Sicherheit sowie einem dynamischen Arbeitsumfeld, das Reisen und spannende Herausforderungen umfasst, sind wir der ideale Ort für neugierige Köpfe, die Großes erreichen wollen.
