Regulatory Affairs Manager (all genders)

We’re looking for a Regulatory Affairs Manager to join our team of medical and software experts. In this role, you’ll play a key part in bringing new AI products to global markets - driving regulatory submissions and strategy, building technical documentation and helping evolve our quality processes to support rapid innovation. Join us to actively shape the next generation of medical software.

Your Challenges

• Drive regulatory clearance for new AI products and modules, focussed on CE and FDA
• Stay ahead of the fast-paced evolution of regulatory requirements and AI capabilities to ensure the compliance of our medical device software
• Contribute to key regulatory areas such as technical documentation, clinical evaluation, risk management, and performance evaluation
• Support the continuous improvement and efficient operation of our Quality Management System

Your Skills

• Degree in life science, engineering, (medical) informatics, medicine or similar
• Initial professional experience in Regulatory Affairs and certification of medical device software
• Experience with regulatory submissions and approval processes (esp. CE and FDA) 
• Knowledge of laws, standards and regulations applicable to medical device software (e.g. MDR 2017/745; 21CFR 820; ISO 13485; IEC 62304; IEC 62366; ISO 14971)
• Initial professional experience in Quality Management is a plus
• Attention to details and problem-solving mindset
• High level of self-motivation, team-working attitude, ability to adapt in a fast-paced environment

We are a close-knit team of 23 professionals with diverse educational and cultural backgrounds, united by a shared commitment to quality, innovation, and collaboration. Our international team thrives in a fast-paced, friendly, and open-minded environment where everyone’s voice is heard.

In this role, you will work in direct collaboration with our Head of Quality & Regulatory Affairs, while also managing your own areas of responsibility. Our agile structure allows for fast and flexible decision-making, empowering team members to take ownership and drive projects forward.

1. 1st Interview (VC with Talent Team and Head of Quality & Regulatory Affairs)
2. technical challenge and results interview (online)
3. final Interview (live)