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

Stellenbeschreibung:

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