Technical Writer – Medical Devices, Combination Products

Responsibilities

• 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.

Demonstrates expertise in the design and development lifecycle of Class III medical devices and combination products, with a strong focus on regulatory compliance and documentation management. Proficient in developing design control documentation and conducting risk management activities in alignment with global medical device regulations.