Quality management & Regulatory Affairs Manager (f/m/x)

Your mission with us

As our Quality Management and Regulatory Affairs Manager (QM & RA Manager), you will take responsibility for implementing regulatory requirements and ensuring the compliant development of innovative medical devices within the digital healthcare sector. You will drive the QM & RA department forward operationally and, together with the team, elevate the company to the next level.

Your Responsibilities

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

Your profile

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

Why us?

• Highly Motivated Team: Be part of our international team of experts, working together to shape the future of healthcare and improve patient care globally.
• Cross‑Functional Collaboration: Our innovative way of working with flat hierarchies allows you to work autonomously and take end‑to‑end responsibility. Our organizational structure provides the foundation for the efficient internal processes needed to make a unique contribution to the development of medical devices.
• Personal Development: Through our feedback‑oriented culture and our focus on individual development opportunities, we aim to continuously support your personal and professional growth.
• 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.
• 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.