Support the development, review, and maintenance of Design History File (DHF) documentation throughout all stages of the design process
Collaborate with the project team to structure, format, and refine core design control deliverables
Participate in design reviews and risk management activities with relevant stakeholders
Support design teams during development activities
Develop and maintain technical, clinical, and biological evaluation documentation
Support preparation of documentation required for global regulatory submissions (EU MDR, FDA, and other markets)
Contribute to continuous improvement of documentation practices, templates, and QMS processes

Minimum 5 years of experience supporting medical device design and development documentation
Proven experience developing design control documentation across multiple lifecycle stages
Direct experience with writing design related documentation (e.g., risk management, human factors, design V&V)
Knowledge of global Medical Device Regulations (EU MDR, FDA, TGA, etc.)
Knowledge of combination product development and associated submission deliverables, including documentation required to support regulatory submissions
Strong organizational skills, detail-oriented to deal with different projects at the same time
Must be fluent in English, both verbally and in writing
Legally able to work in The Netherlands

Technical Writer – Medical Devices, Combination Products

Key skills