Technical Writer
Vor 6 Tagen
Your mission
We want you to join our early-stage university spin-off that has its ISO 13485 certification. We are looking for an exceptional Technical Writer with a passion for precision, clarity, and scientific rigor. In this role, you will be the central interface between Software Development and Quality & Regulatory Affairs ensuring that our technical documentation meets the highest standards of accuracy and compliance.
You will use your deep understanding of complex technical systems and your outstanding writing skills to:
- 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 for our SaMD, ensuring sound risk governance and mitigation.
- Enhance and maintain documentation aligned with the Product Development Lifecycle (IEC 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.
Your profile
We are seeking someone with exceptional writing skills and the technical depth to translate complex concepts into precise, accessible documentation. You are a person who obsesses over clarity, correctness, structure, and consistency — and takes pride in producing world-class documentation.
- A 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.
Why us?
- Contribute to products that will have a measurable impact on the lives of patients.
- You will be working with modern tooling in an agile and dynamic environment.
- We are an interdisciplinary team of highly motivated, skilled and ambitious people. Individual contributions count…a lot
About us
We are a Munich-based startup building a digital twin platform for respiratory diseases – a monolithic digital toolset that elevates the actions of decision makers in healthcare and life sciences through physics-based simulation, AI, and data science. In the hands of industrial users, it fosters their understanding of pulmonary drug delivery to inform, accelerate and de-risk trial design and execution. In the hands of physicians, it will offer personalized treatment perspectives to improve the odds of survival and recovery in millions of cases of respiratory complication each year, such as Acute Respiratory Distress Syndrome (ARDS). Anywhere at any time.
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