Regulatory Affairs Manager (all genders) bei Laralab in München

Arbeitsbeschreibung - Regulatory Affairs Manager (all genders)

Your Role

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.

Your Challenge

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

Be Part of Our Story – there is a lot in it for you!

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

Application and Contact

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! [email protected] - www.laralab.com

About us

LARALAB’s goal is to revolutionize the planning of cardiac interventions and improve the lives of patients worldwide. We are developing cloud-based planning software powered by deep learning technology to support the innovation of new, minimally invasive cardiac procedures, and to make these procedures available to patients in need. We have collaborations with leading clinics and medical companies, and are backed by strong investors.

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Über das Unternehmen

Laralab