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