Senior Quality Management and Regulatory Affairs Manager

ImFusion; München; Vor Ort; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

A leading medical technology firm in Munich seeks an experienced Regulatory Manager to provide oversight on regulatory and quality requirements, particularly MDR and FDA. In this full-time role, you will guide documentation processes and support compliance within a dynamic team. The ideal candidate holds a Master's degree in a relevant field and has proven experience in quality management. Join us to make a significant impact in the medical imaging domain with a competitive salary and comprehensive benefits.

Leistungen

Competitive salary

Comprehensive benefits package

Team events

Qualifikationen

• 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.
• Ability to manage multiple projects and deadlines effectively.

Aufgaben

• Provide guidance on regulatory and quality requirements including MDR and FDA for software projects.
• Create technical documentation for projects together with software development teams.
• Develop, implement and monitor quality policies, procedures and KPIs.
• Promote a culture of quality and compliance across the organization.

Kenntnisse

Proofreading

Adobe Acrobat

FDA Regulations

Manufacturing & Controls

Biotechnology

Clinical Trials

Research & Development

GLP, cGMP

Product Development

Chemistry

Writing Skills

Ausbildung

Masters degree in Engineering, Computer Science or related field

Jobbeschreibung

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.

Responsibilities

• Provide guidance on regulatory and quality requirements including MDR and FDA requirements for our in‑house and customer software projects.
• Create technical documentation for our industry projects together with our software development teams.
• Provide guidance and support on MDR and FDA compliant 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.

Profile

• Masters degree in Engineering, Computer Science or related field.
• Excellent understanding of software development processes and documentation requirements.
• Knowledge of the technical principles of AI models and 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 regulatory domains.

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.).
• 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 are an equal‑opportunity employer 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.

Key Skills

• Proofreading
• Adobe Acrobat
• FDA Regulations
• Manufacturing & Controls
• Biotechnology
• Clinical Trials
• Research & Development
• GLP, cGMP
• Product Development
• Chemistry
• Writing Skills

Employment type

Full‑time

Location

Regulatory Management • Munich, Bavaria, Germany

Required experience

Manager