Technical Editor/Writer providing editorial and writing support within government programs. Conducting quality assurance and managing multiple writing assignments for compliance and operational documentation.
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!
Job title
Job type
Experience level
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Not specified
Degree requirement
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