Hybrid Technical Writer – Software as Medical Device

at Ebenbuild

• Job title: Technical Writer – Software as Medical Device
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Munchen, Germany

About the role

• Technical Writer ensuring compliance and excellence in documentation for medical software startup. Serving as the interface between development and regulatory affairs in an agile environment.

Responsibilities

• Serve as the technical bridge between Software Development and Quality & Regulatory Affairs.
• Prepare, structure, and maintain comprehensive technical documentation in accordance with EU MDR, FDA, and internal quality system requirements.
• Contribute to the implementation of robust risk management processes (ISO 14971) for our SaMD, ensuring sound risk governance and mitigation.
• Enhance and maintain documentation aligned with the Product Development Lifecycle (IEC 62304) in close collaboration with the Software Development Team.
• Support the definition, refinement, and traceability of Software Requirements within the development lifecycle.
• Research, review, and compile internal and external data to support the conformity assessment of our SaMD.
• Draft clear, technically accurate statements for submissions to international regulatory authorities.
• Conduct structured gap analyses of relevant laws, regulations, and standards for our SaMD.
• Champion documentation excellence across the organization, ensuring consistency, clarity, and completeness.

Requirements

• 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 — ideally within MedTech, software, or regulated industries.
• Experience in regulatory affairs including creating structured technical documentation for MDR/FDA submissions is a strong plus.
• 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, high attention to detail, and the ability to structure complex information logically.
• Outstanding written and verbal communication skills in English — with an emphasis on clarity, correctness, and conciseness.
• German language skills are a plus.
• A proactive, independent, and solution-oriented working style.
• A hands-on attitude and the ability to thrive in a fast-moving startup environment with high quality standards.

Benefits

• Contribute to products that will have a measurable impact on the lives of patients.
• Working with modern tooling in an agile and dynamic environment.
• Interdisciplinary team of highly motivated, skilled and ambitious people.
• Individual contributions count…a lot!