Regulatory Affairs Manager (all genders)
LARALAB GmbH
Regulatory Affairs Manager (all genders)
Regulatory Affairs Manager (all genders)
LARALAB GmbH
LARALAB GmbH
- MunichOffice locations
- Full-time
- Junior, Midlevel or SeniorYou need at least 1-2 years of working experience.
- Hybrid workYou need to come to the office every week.
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.
Tasks
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
Requirements
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
Team
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.
Application process
1. 1st Interview (VC with Talent Team and Head of Quality & Regulatory Affairs)
2. technical challenge and results interview (online)
3. final Interview (live)
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Benefits
Flexible Working Hours
We cherish our collaborative work environment in the office but appreciate dedicated, remote focus time. The choice and responsibility are yours.
Workation
We cherish our collaborative work environment in the office but appreciate dedicated, remote focus time. The choice and responsibility are yours.
Job-Rad
Bike Program
Cycling isn't just the best way to get to the office, but a passion for many of us. That’s why we offer options to get a good bike.
Events
Regular team events, ranging from mountain trips to Schliersee half-marathons to office parties.
Health Program
Sports & Health Program
We love sports and care for our team’s well being! That’s why we offer EGYM Wellpass to employees.
Permanent contract
Part-Time
Professional Development
Meals
Well-Connected by Public Transport
Dogs Allowed
Freie Getränke
LARALAB GmbH
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