Ocumeda
Senior Software Engineer – Medical AI (EU MDR)(m/w/x)
Vollzeitmit HomeofficeSenior
München
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IMImFusion GmbH
Senior Quality Management and Regulatory Affairs Manager(m/w/x)
München
Vollzeitmit HomeofficeSenior
AI/ML
Nejo KI-Zusammenfassung
Overseeing regulatory compliance and MDR/FDA documentation for medical AI software projects, maintaining ISO 13485 QMS in medical imaging R&D. Proven industry experience in med-tech software regulatory compliance and ISO 13485, IEC 62304, MDR, FDA knowledge required. Bike leasing and Deutschlandticket.
Anforderungen
- Master’s degree in Engineering, Computer Science, or related field
- Excellent understanding of software development processes and documentation requirements
- Knowledge of technical principles of AI models and software cyber-security
- Proven industry experience in quality management and regulatory affairs in med-tech software
- 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
- Willingness to continuously learn and extend skills in technical and regulatory domains
- Hands-on software development experience (optional)
Aufgaben
- Provide guidance on regulatory and quality requirements for software projects
- Create technical documentation for industry projects with software development teams
- Support MDR and FDA conformant documentation for medical AI models
- Maintain and improve the Quality Management System 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 processes and products
- Promote a culture of quality and compliance across the organization
- Explore opportunities for growth into a team lead role
Berufserfahrung
- 2 - 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Firmenfahrrad
- Bike leasing
Gesundheits- & Fitnessangebote
- Sports programs
Öffi Tickets
- Deutschlandticket
Team Events & Ausflüge
- Team events
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens ImFusion GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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IMImFusion GmbH
Senior Quality Management and Regulatory Affairs Manager(m/w/x)
München
Vollzeitmit HomeofficeSenior
AI/ML
Nejo KI-Zusammenfassung
Overseeing regulatory compliance and MDR/FDA documentation for medical AI software projects, maintaining ISO 13485 QMS in medical imaging R&D. Proven industry experience in med-tech software regulatory compliance and ISO 13485, IEC 62304, MDR, FDA knowledge required. Bike leasing and Deutschlandticket.
Anforderungen
- Master’s degree in Engineering, Computer Science, or related field
- Excellent understanding of software development processes and documentation requirements
- Knowledge of technical principles of AI models and software cyber-security
- Proven industry experience in quality management and regulatory affairs in med-tech software
- 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
- Willingness to continuously learn and extend skills in technical and regulatory domains
- Hands-on software development experience (optional)
Aufgaben
- Provide guidance on regulatory and quality requirements for software projects
- Create technical documentation for industry projects with software development teams
- Support MDR and FDA conformant documentation for medical AI models
- Maintain and improve the Quality Management System 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 processes and products
- Promote a culture of quality and compliance across the organization
- Explore opportunities for growth into a team lead role
Berufserfahrung
- 2 - 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Firmenfahrrad
- Bike leasing
Gesundheits- & Fitnessangebote
- Sports programs
Öffi Tickets
- Deutschlandticket
Team Events & Ausflüge
- Team events
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens ImFusion GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
ImFusion GmbH
Branche
Healthcare
Beschreibung
The company is a R&D consulting firm specializing in medical imaging technologies, AI, and robotics.
Noch nicht perfekt?
- Ocumeda
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