You oversee regulatory compliance for AI products, ensuring they meet evolving standards. Your role includes managing documentation and evaluations while improving the Quality Management System.
Anforderungen
- •Degree in life science or engineering
- •Initial professional experience in Regulatory Affairs
- •Experience with regulatory submissions
- •Knowledge of medical device regulations
- •Initial professional experience in Quality Management is a plus
- •Attention to details and problem-solving mindset
- •High level of self-motivation and team-working attitude
Deine Aufgaben
- •Drive regulatory clearance for new AI products.
- •Ensure compliance with evolving regulatory requirements.
- •Contribute to technical documentation and clinical evaluation.
- •Manage risk and performance evaluation processes.
- •Support the improvement of the Quality Management System.
Deine Vorteile
Regulatory Affairs expertise impact
Growing international company
Flexible working hours
Remote working possibilities
Company sports program
Free snacks and drinks
Office in Munich
Original Beschreibung
## Regulatory Affairs Manager (all genders)
###### Permanent employee, Full-time ·München
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##### 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