ImFusion GmbH
Senior Quality Management and Regulatory Affairs Manager(m/w/x)
Full-timeWith HomeofficeSenior
München
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EbenbuildTechnical Writer - Software as Medical Device(m/w/x)
München
Full-timeWith Home OfficeExperienced
Description
In this role, you will act as a vital link between Software Development and Quality & Regulatory Affairs, ensuring that technical documentation is precise and compliant. Your responsibilities include maintaining documentation standards, supporting risk management, and contributing to regulatory submissions.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Exceptional writing skills
- •Degree in medical technology, biomedical or mechanical engineering, computer science, or equivalent technical qualifications
- •Proven experience in technical writing for complex technical or scientific domains
- •Experience in regulatory affairs, including creating structured technical documentation for MDR/FDA submissions
- •Familiarity with software development processes and documentation in a MedTech or high-compliance environment
- •Solid understanding of ISO 13485, EU MDR, FDA SaMD guidance, and IEC 62304
- •Strong analytical thinking and high attention to detail
- •Outstanding written and verbal communication skills in English
- •Proactive, independent, and solution-oriented working style
- •Hands-on attitude and ability to thrive in a fast-moving startup environment
Education
Bachelor's degree
OR
Vocational certification
Work Experience
2 - 5 years
Tasks
- •Serve as the technical bridge between Software Development and Quality & Regulatory Affairs
- •Prepare, structure, and maintain comprehensive technical documentation
- •Ensure documentation meets EU MDR, FDA, and internal quality system requirements
- •Contribute to robust risk management processes for Software as Medical Device
- •Enhance documentation aligned with the Product Development Lifecycle
- •Collaborate closely with the Software Development Team
- •Support the definition and refinement of Software Requirements
- •Ensure traceability within the development lifecycle
- •Research and compile data for conformity assessment of Software as Medical Device
- •Draft clear statements for submissions to international regulatory authorities
- •Conduct gap analyses of laws, regulations, and standards
- •Champion documentation excellence across the organization
Tools & Technologies
ISO 13485EU MDRFDA SaMD guidanceIEC 62304
Languages
English – Business Fluent
German – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Ebenbuild 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.
Not a perfect match?
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EB
EbenbuildTechnical Writer - Software as Medical Device(m/w/x)
München
Full-timeWith Home OfficeExperienced
New Job?Nejo!
The AI Job Search Engine
Description
In this role, you will act as a vital link between Software Development and Quality & Regulatory Affairs, ensuring that technical documentation is precise and compliant. Your responsibilities include maintaining documentation standards, supporting risk management, and contributing to regulatory submissions.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Exceptional writing skills
- •Degree in medical technology, biomedical or mechanical engineering, computer science, or equivalent technical qualifications
- •Proven experience in technical writing for complex technical or scientific domains
- •Experience in regulatory affairs, including creating structured technical documentation for MDR/FDA submissions
- •Familiarity with software development processes and documentation in a MedTech or high-compliance environment
- •Solid understanding of ISO 13485, EU MDR, FDA SaMD guidance, and IEC 62304
- •Strong analytical thinking and high attention to detail
- •Outstanding written and verbal communication skills in English
- •Proactive, independent, and solution-oriented working style
- •Hands-on attitude and ability to thrive in a fast-moving startup environment
Education
Bachelor's degree
OR
Vocational certification
Work Experience
2 - 5 years
Tasks
- •Serve as the technical bridge between Software Development and Quality & Regulatory Affairs
- •Prepare, structure, and maintain comprehensive technical documentation
- •Ensure documentation meets EU MDR, FDA, and internal quality system requirements
- •Contribute to robust risk management processes for Software as Medical Device
- •Enhance documentation aligned with the Product Development Lifecycle
- •Collaborate closely with the Software Development Team
- •Support the definition and refinement of Software Requirements
- •Ensure traceability within the development lifecycle
- •Research and compile data for conformity assessment of Software as Medical Device
- •Draft clear statements for submissions to international regulatory authorities
- •Conduct gap analyses of laws, regulations, and standards
- •Champion documentation excellence across the organization
Tools & Technologies
ISO 13485EU MDRFDA SaMD guidanceIEC 62304
Languages
English – Business Fluent
German – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Ebenbuild 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
Ebenbuild
Industry
Healthcare
Description
The company is a Munich-based startup building a digital twin platform for respiratory diseases, enhancing decision-making in healthcare.
Not a perfect match?
- ImFusion GmbH
Senior Quality Management and Regulatory Affairs Manager(m/w/x)
Full-timeWith HomeofficeSeniorMünchen - Tentamus Group GmbH
Naturwissenschaftler/Ingenieur als Senior Consultant Regulatory Affairs & Technical Documentation Medical Devices(m/w/x)
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Full-timeWith HomeofficeManagementMünchen - noris network AG
Technischer Redakteur(m/w/x)
Full-timeRemoteSeniorNürnberg, Aschheim, Berlin, Hof - Parloa
Documentation Specialist(m/w/x)
Full-timeWith HomeofficeExperiencedBerlin, München