Regulatory Affairs Manager (all genders)

LaraLab; Deutschland; Hybrid; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

LaraLab is seeking a Regulatory Affairs Manager to play a central role in bringing new AI products to global markets. The successful candidate will drive regulatory submissions, build technical documentation, and support quality processes, while working collaboratively in a dynamic environment with an innovative team.

Leistungen

Flexible working hours and remote working possibilities

Company sports program (Wellpass + JobRad)

Free snacks and drinks

Conveniently located office in Munich

Qualifikationen

• 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.

Aufgaben

• Drive regulatory clearance for new AI products and modules focused on CE and FDA.
• Contribute to regulatory areas such as technical documentation, risk management, and performance evaluation.
• Support the efficient operation of the Quality Management System.

Kenntnisse

Regulatory Affairs

Problem-solving

Attention to details

Team-working

Adaptability

Ausbildung

Degree in life science, engineering, (medical) informatics, medicine or similar

Jobbeschreibung

Read job description in: English EN
German

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![e-mail] - www.laralab.com