Your mission
As Quality & Regulatory Affairs Lead in our Quality Management team, you will take ownership of quality and regulatory strategy across our in-house SaMD product and customer projects where our software is integrated into medical device systems (SiMD) - with a strong focus on interventional navigation and planning.
This is a hands-on leadership role: you will actively contribute to documentation, audits, and QMS work while building and growing the Quality Management team over time.
Your responsibilities:
- Define strategy for meeting regulatory and quality requirements, including MDR and FDA expectations, for our in-house and customer software projects
- Provide guidance and support on MDR/FDA-conformant documentation for medical device software, including navigation and interventional planning applications
- Maintain and continuously improve our QMS in alignment with ISO 13485
- Develop, implement, and monitor quality policies, procedures, and KPIs
- Coordinate internal audits and prepare for external audits
- Monitor regulatory changes and assess their impact on company processes, products, and customer projects
- Promote a culture of quality and compliance across the organization
- Lead the business development of the Quality Management team (e.g., supporting customer discussions, shaping service offerings, contributing to proposals and project scoping)
- Build up the Quality Management team over time, including mentoring, hiring, and defining scalable processes
- Stay hands-on in documentation and compliance work, especially in the early phase while the team is small
Your profile
- Several years of experience in quality management and regulatory affairs for medical device software (SaMD and/or SiMD)
- Strong knowledge of ISO 13485, MDR, and FDA expectations (especially for software and imaging/navigation products with AI components)
- Experience coordinating audits and working with external auditors
- Ability to combine hands-on execution with pragmatic leadership in a growing company environment while managing uncertainty
- Demonstrated ownership of complex initiatives or projects end-to-end
- Strong communication skills and confidence working with engineers, leadership, and customers
- Motivation to build and grow a quality organization from the ground up
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