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!

Become part of the ONCARE family and apply today with your complete application documents, stating your earliest possible starting date and your salary expectations.

We are looking forward to hearing from you!

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