Senior Quality Management and Regulatory Affairs Manager

Permanent employee, Full-time · Munich

Your mission

ImFusion is an independent R&D company based in Munich. We help our customers to drive innovation in Medical Imaging based on our software platform for Image Processing, Computer Vision, AI and Robotics. We wish to expand our team with talented and motivated people to help us develop and commercialize advanced medical products in collaboration with renowned customers.

As Senior Quality Management and Regulatory Affairs Manager in the Quality Management team you will have the following responsibilities:

Provide guidance on regulatory and quality requirements, including MDR and FDA requirements, for our in-house and our customer software projects
Create technical documentation for our industry projects together with our software development teams
Provide guidance and support on MDR and FDA conformant documentation of medical AI models
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 and products
Promote a culture of quality and compliance across the organization
Possibility to grow into a team lead role

This position is offered as a full-time, permanent role based in our Munich office. Hybrid work is possible.

Your profile

Master’s degree in Engineering, Computer Science or related field
Excellent understanding of software development processes and documentation requirements
Knowledge on the technical principles of AI models and on the technical aspects of software cyber-security
Proven industry experience in quality management and regulatory affairs in a med-tech software environment
Strong knowledge of ISO 13485, IEC 62304, MDR and FDA regulations for med-tech software
Strong organizational, analytical, and communication skills
Ability to manage multiple projects and deadlines effectively
Excellent problem-solving skills and attention to detail
Able and willing to continuously learn and extend your skills in both the technical and the regulatory domain
Hands-on software development experience (optional)

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

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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!

Apply for this job

We are looking forward to your application!

Thank you for your interest in ImFusion!

Please fill out the following form. Should you have difficulties with the upload of your data, please send an email to jobs@imfusion.com

We’d love to stay in touch with you – even if it doesn’t work out this time.
If you're happy for us to do so, we'd like to keep your application on file in our talent pool for up to 24 months after the current process concludes. This allows us to contact you should a future opportunity match your profile.