Position Overview
We are looking for a Technical Writer to join our R&D department and support the generation of high-quality documentation throughout the medical device design and development process. The role focuses on developing and maintaining technical, pre-clinical and clinical documents that form part of the Design History File (DHF) and provide essential input for worldwide regulatory submissions.
The ideal candidate has a solid understanding of design controls, risk management, and the medical device regulatory landscape, ensuring that all R&D deliverables meet ISO 13485, QSR, and internal quality system requirements.
Key Responsibilities
- Author, edit, and maintain R&D documentation in alignment with design control processes, including design inputs/outputs, verification and validation protocols/reports, and risk management documentation (per ISO 14971);
- Develop and maintain technical, clinical, and biological evaluation documents (e.g., CEP/CER, BEP/BER) in close collaboration with key stakeholders;
- Designing and conducting systematic literature searches;
- Write and maintain the Instructions for Use (IFUs) and other labelling documentation in line with the intended purpose of Kuros products;
- Identifying, appraising, and analyzing all relevant (clinical, PMS, marketing, and testing data) from multiple sources and creating a comprehensive scientific review;
- Ensure consistency, traceability, and compliance across DHF elements and other R&D documentation;
- Support cross-functional teams by compiling data, literature, and technical summaries to substantiate safety and performance of Kuros products;
- Contribute to continuous improvement of R&D documentation, templates, and processes within the QMS.
You will be part of the R&D team, working with R&D scientists and technicians on the development of implantable medical devices in the musculoskeletal field. Working closely with other stakeholders within the company like QA/RA, process engineers and medical/clinical affairs.
Skills and abilities desired:
- You have a technical or scientific degree (MSc or Ph.D.) in chemistry, (medical) biology, biomedical technology, or similar;
- Minimal 3-5 years of working experience with writing technical documents for high risk (class III, implantable) medical devices;
- Knowledge of global Medical Device Regulations (EU MDR, FDA, TGA, etc.), particularly in relation to generating and evaluating clinical data of medical devices;
- Direct experience with writing clinical documentations;
- Pragmatic, accurate, analytical, enjoying the dynamics of dealing with several stakeholders, business processes, regulatory and clinical challenges;
- Strong organizational skills, detail-oriented to deal with different projects at the same time;
- Must be able to work well independently, as well as being able to work cooperatively in a team of professionals
- Fluent in English, both verbally and in writing;
- Legally able to work in The Netherlands.
