Senior Quality Management and Regulatory Affairs Manager

Your mission

As a Quality Systems & Technical Documentation Specialist in our Quality Management team, you will support the creation of technical documentation for both our in-house SaMD product and customer projects where our software is integrated into medical device systems (SiMD), especially in the area of interventional navigation and planning.

You will work closely with our software development teams and contribute to scalable documentation processes aligned with ISO 13485, MDR and FDA expectations.

Your responsibilities

• Create technical documentation for customer solutions developed using our SDK together with our software development teams
• Create the technical documentation for our in-house SaMD, ensuring MDR/FDA-ready documentation structures
• Improve internal tooling and processes to deliver documentation faster and increase efficiency
• Maintain and continuously improve our QMS in alignment with ISO 13485
• Contribute to internal and external audits by preparing documentation, evidence, and traceability artifacts

Your profile

• Experience in quality, technical documentation, or regulated documentation in medical device software (SaMD and/or SiMD)
• Familiarity with ISO 13485 and documentation expectations under MDR and/or FDA
• Experience in collaborating with software development teams and translating technical content into compliant documentation
• Strong attention to detail, structured working style, and good communication skills
• Exposure in medical imaging, navigation and interventional clinical workflows is a strong plus

Why us?

• Be part of an international, dynamic, and highly qualified team where you can make a real impact and shape the future together with us
• Enjoy the agility of a start-up combined with the security of an established company
• Receive a competitive salary and a comprehensive benefits package (e.g., bike leasing, sports programs, Deutschlandticket, etc.)
• We celebrate successes together at various team events such as our summer party or Oktoberfest