Quality and Regulatory Affairs Manager - Healthcare Technology (f/m/d)

Job description

At myoncare , we don’t just develop software – we are building an international health ecosystem that redefines care. Our platform connects patients, clinics, doctors, and partners within a single, intelligent system, creating something unprecedented: continuous, secure, and personalized care around the clock. As part of our Quality & Regulatory Affairs team, you ensure that our innovation stands on a strong foundation of quality and compliance. You turn regulatory requirements into clear, practical standards and actively help shape and improve our quality management system across the organization, making a real impact on the safety and reliability of our products. Tasks: - Perform gap analyses of regulatory documents and QMS documentation, derive and implement required adaptations in documentation and processes - Keep regulatory documentation such as laws, standards, regulations and guidance documents up-to-date and ensure continuous compliance of QMS and product to these requirements - Identify and execute regulatory pathways for successful market access - Actively promote improvement in QMS processes - Administration and maintenance of the QMS documentation - Advise other depart...