Would you like to play a central role in this growth process? 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.

• 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

• 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

• Using your Regulatory Affairs expertise to make a positive impact on people's lives
• The chance to be part of a growing international company and a passionate, highly skilled team
• Flexible working hours and remote working possibilities
• Company sports program (Wellpass + JobRad) and free snacks and drinks
• An office conveniently located in the heart of Munich

Sounds interesting? We’d love to hear from you! Send us your CV, a brief motivation letter, and any relevant certificates. Have questions? We’ll be happy to answer them! jobs@laralab.de - www.laralab.com