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

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 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 your own actions
• Drive to identify potential for improvement and to find solutions for stakeholders
• Thoroughness in everything you do, a great attention to detail and the ability to quickly adapt to new problems even on tight schedules
• Excellent time management and organizational skills
• Effective communication in international and interdisciplinary teams and active listening skills
• Excellent English proficiency (written and spoken), German proficiency is beneficial

Benefits

• Competitive salary with performance-based growth
• Central located office with plenty of lunch options
• Global team shaping the future of healthcare
• Coffee and tea stations for daily recharge
• Employee discounts
• Flat hierarchies with direct contact to decision-makers

Contribute to the digitalization of healthcare and take visionary step into the future with us!

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