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.
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 departments in daily regulatory and quality-related activities Plan and perform employee trainings Requirements At least three years of experience in Regulatory Affairs or Quality Department for medical devices, ideally of medical device software At least two years of experience in managing QM systems covering ISO 13485 In-depth knowledge of MDR 2017/745, EN ISO 13485:2016, CFR part 820 and relevant sections of the FD&C Act Experience in generating and adapting SOPs and Working Instructions together with respective departments such as Research & Development and Product Management Experience in Regulatory Affairs in USA markets beneficial Experience in medical device vigilance beneficial Knowledge of ISO 14971, EN 62304 and EN 62366 beneficial Independent working and a strong sense of responsibility for you.