Senior Quality Management and Regulatory Affairs Manager

vor 16 Stunden

Munich, Bayern, Deutschland ImFusion GmbH Vollzeit

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

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

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