Quality & Regulatory Affairs Lead - Medical Device Software (SaMD/SiMD)

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

About us

ImFusion GmbH is a growing company located in Munich, conducting research, development and consulting in advanced medical image computing technologies and computer vision. Our customers include small and large medical device companies as well as academic research labs. We wish to expand our team with talented and motivated people.

We are an equal opportunity employer and are committed to creating an inclusive and diverse workplace where everyone feels valued and empowered. We celebrate diversity and welcome applications from people of all backgrounds, regardless of race, religion, color, national origin, gender, gender identity, sexual orientation, age, marital status, disability, or any other legally protected characteristic. Our goal is to foster a culture of belonging, where different perspectives drive innovation and success.

You think you can be a good fit? We'd love to hear from you!