Support the full design and development lifecycle, from early concept through verification, validation, and regulatory submission for class III medical devices and combination products
Support the development, review, and maintenance of Design History File (DHF) documentation throughout all stages of the design process, including design inputs/outputs, verification and validation protocols/reports, and risk management documentation
Collaborate with the project team to structure, format, and refine core design control deliverables, ensuring clarity, consistency, traceability and compliance with quality system requirements
Participate in design reviews and risk management activities with relevant stakeholders
Support design teams during development activities, ensuring documentation aligns with technical progress and regulatory expectations
Develop and maintain technical, clinical, and biological evaluation documentation
Develop and contribute for the preparation of documentation specific to combination products to support early interactions with the FDA and other regulatory bodies
Conduct systematic literature reviews to support safety and performance claims
Compile risk management documentation in accordance with ISO 14971
Contribute to development of Instructions for Use (IFUs) and product labeling
Support preparation of documentation required for global regulatory submissions (EU MDR, FDA, and other markets)

You have a technical or scientific degree (MSc or Ph.D.) in chemistry, (medical) biology, biomedical technology, or similar
Minimum 5 years of experience supporting medical device design and development documentation, preferably high-risk medical devices, preferably Class III implantable devices and/or combination products
Proven experience developing design control documentation across multiple lifecycle stages
Direct experience with writing design related documentations (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
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.

Technical Writer – Medical Devices, Combination Products

Key skills