Senior Quality Management and Regulatory Affairs Manager

ImFusion GmbH; München; Hybrid; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A medical imaging innovation firm in Munich is seeking a Senior Quality Management and Regulatory Affairs Manager. This full-time role involves providing regulatory guidance, creating technical documentation, and maintaining quality management systems. The ideal candidate holds a Master’s degree in engineering, has experience in med-tech quality management, and is familiar with ISO standards and FDA regulations. Hybrid work options are available.

Leistungen

Competitive salary

Comprehensive benefits package

Team events such as summer parties and Oktoberfest

Bike leasing programs

Sports programs

Deutschlandticket

Qualifikationen

• Experience in quality management and regulatory affairs in a med-tech software environment.
• Strong knowledge of ISO 13485, IEC 62304, MDR and FDA regulations.
• Organizational and analytical skills are essential.

Aufgaben

• Provide guidance on regulatory and quality requirements for projects.
• Create technical documentation with software development teams.
• Develop, implement, and monitor quality policies and procedures.

Kenntnisse

Regulatory and quality requirements

Technical documentation

Knowledge of MDR and FDA regulations

Quality management system (QMS)

Analytical skills

Communication skills

Problem-solving skills

Ausbildung

Master’s degree in Engineering, Computer Science or related field

Tools

ISO 13485

IEC 62304

Jobbeschreibung

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