Beschreibung

Your roleConnected devices, digital therapeutics and intelligent injection systems are reshaping how patients receive treatment, and you will help make that future safe, secure and compliant. You will lead the quality and regulatory strategy for connected health products from early concept through post-market surveillance. As the quality lead for digital health and software as a medical device, you will own risk management, software quality and cybersecurity compliance across the product lifecycle. You will translate evolving technology and regulatory expectations into clear, practical processes that guide engineering, clinical operations and other cross-functional partners.  You will help close the gaps between rapid technology development and the quality and compliance requirements of the healthcare environment. Working closely with a five-member team, you will collaborate across digital health, cybersecurity, data privacy, electronic autoinjectors, manufacturing quality, clinical evaluation and post-market activities. You will support design controls, technical documentation and clinical evaluation or investigation for products intended for international markets. You will build trusted relationships with auditors, notified bodies, senior stakeholders, external partners and suppliers, influencing decisions even when you do not have direct authority. Based in Eysins, Switzerland, this role offers flexible remote work of up to two days per week. If you are motivated by innovation that keeps patients safe, you will have the opportunity to shape how connected care reaches people around the world. Who you areYou hold an engineering degree or equivalent qualification, complemented by relevant training in medical device quality, regulatory affairs, software lifecycle processes, cybersecurity or a related discipline. You have at least 10 years of experience in medical device quality and regulatory affairs, including connected or software-driven products.You have strong practical knowledge of the standards and regulations governing quality management systems, risk management, software lifecycle processes, usability and post-market surveillance.You bring hands-on expertise in medical device cybersecurity and data privacy, including threat modelling, security risk management and vulnerability handling.You have supported design controls, technical documentation and clinical evaluation or investigation for devices placed on international markets.You have experience with digital health applications or software as a medical device; experience with electronic drug delivery systems and manufacturing quality is an advantage.You turn complex and changing technology or regulatory expectations into workable processes and communicate confidently with auditors, notified bodies and senior stakeholders in English.You have experience managing external partners and suppliers, including technical agreements, supplier qualification and oversight of outsourced development and manufacturing.You are curious about new technologies, collaborative by nature and energized by work that protects patients; experience applying artificial intelligence in healthcare or medical devices is a plus. Department: HC-GM-QMAC Connected Health Quality Role level: Expert Level 3