Cross-departmental maintenance and optimization of the Quality Management System according to ISO 13485:2016 and EU-MDR 2017/745.
Creation, review, and maintenance of Technical Documentation in accordance with MDR for medical devices.
Planning, gathering, and implementing regulatory requirements as well as approval regulations within the EU and internationally.
Promoting awareness and training employees on applicable regulatory requirements.
Planning, conducting, and evaluating internal and external audits, including preparation, follow-up, and implementation of audit measures.

Relevant degree in a scientific or technical field.
Initial professional experience in Regulatory Affairs and/or Quality Management, ideally within the field of SaMD (Software as a Medical Device).
Experience in the field of digital health applications (DiGA) or within a startup/scale-up environment is a plus.
A structured and systematic organizational talent with a pragmatic approach and a keen eye for detail.
Excellent oral and written communication and presentation skills in German and English.

Comprehensive Employee Benefits: We support your work-life balance and promote your health through subsidies for EGYM Wellpass and Urban Sports Club.
Additionally, you will benefit from our contributions to the Deutschland Ticket (public transport) and our company pension scheme.
Relaxed Working Atmosphere: We ensure your well-being in our office in the heart of Hamburg—both through refreshments and great perks such as Corporate Benefits, activities, and company events.
Your Workspace: We take it for granted that you’ll be equipped with a MacBook and an ergonomic workstation; flexible working hours are also standard.

Quality Management – Regulatory Affairs Manager

Key skills