We are looking for a Regulatory Affairs and Quality Manager to join our team of medical and software experts. You would be in the QM / Regulatory Affairs team and manage the regulatory clearance of our products.

• Maintain and improve processes within our Quality Management System to comply withISO 13485 and 21CFR 820
• Manage regulatory affairs actions to file for CE certification and FDA approval
• Lead audits and inspections by regulatory bodies
• Define regulatory strategies for AI-based products
• Ensure compliance with standards applicable to medical device software development

• Degree in science, engineering, (medical) informatics or medicine
• Professional experience in regulatory affairs and certification of medical device software
• Professional experience in Process and Quality Management 
• Profound knowledge of laws, standards and regulations for licensing medical devices and for business processes of medical device manufacturers (e.g. MDR; 21CFR 820; ISO13485; IEC 62304; IEC 62366; ISO 14971)
• Profound knowledge of the FDA approval process for medical devices
• High level of self-motivation, flexible mindset, ability to adapt in fast-paced environment and proactive in finding solutions

• Work in one of the most fulfilling and meaningful applications of software development
• The chance to be part of a growing international company
• Being part of a passionate and highly skilled team in a dynamic startup environment
• Ownership and many opportunities for personal growth
• An office centrally located in Munich, Jobbike, EGYM Wellpass and much more

Sounds interesting? Send us your CV, motivation letter, and relevant certificates.Have questions? We’ll be happy to answer them, contact us at jobs@laralab.de.