Would you like to play a role in this growth process? We are looking for a Quality Management / Regulatory Affairs Working Student to join our team of medical and software experts. You will contribute to the development and regulatory approval process of our impactful software products, with the goal of making them available to patients. You will work closely with Quality Management, Regulatory Affairs and Software Development in an exciting position.

• Support software releases and compile technical documentation for regulatory submissions for our AI-based software products (e.g. FDA 510(k), MDR)
• Ensure compliance with standards applicable to medical device software development. 
• Perform software testing
• Support on audits and inspections by regulatory authorities.

• Analytical and structured working style with ability to quickly adapt to new topics and take overresponsibility
• Interest in learning about regulatory affairs and certification of medical device software, including CE marking and FDA approval.
• Basic knowledge and understanding of the regulatory frameworks and relevant standards for medical software (e.g. IEC 62304, ISO 14791)
• High level of self-motivation, flexible mindset, ability to adapt in fast-paced environment and proactive in finding solutions
• Passion in medical devices, cutting edge medical technology and artificial intelligence

• 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, cover letter, and relevant certificates. Have questions? We’ll be happy to answer them! jobs@laralab.de