Ocumeda
Senior Software Engineer – Medical AI (EU MDR)(m/w/x)
Full-timeWith HomeofficeSenior
München
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IMImFusion GmbH
Senior Quality Management and Regulatory Affairs Manager(m/w/x)
München
Full-timeWith Home OfficeSenior
AI/ML
Nejo AI Summary
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.
Requirements
- 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)
Tasks
- 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
Work Experience
- 2 - 5 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
Company Bike
- Bike leasing
Healthcare & Fitness
- Sports programs
Public Transport Subsidies
- Deutschlandticket
Team Events
- Team events
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ImFusion GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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IMImFusion GmbH
Senior Quality Management and Regulatory Affairs Manager(m/w/x)
München
Full-timeWith Home OfficeSenior
AI/ML
Nejo AI Summary
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.
Requirements
- 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)
Tasks
- 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
Work Experience
- 2 - 5 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
Company Bike
- Bike leasing
Healthcare & Fitness
- Sports programs
Public Transport Subsidies
- Deutschlandticket
Team Events
- Team events
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ImFusion GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
ImFusion GmbH
Industry
Healthcare
Description
The company is a R&D consulting firm specializing in medical imaging technologies, AI, and robotics.
Not a perfect match?
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