Technical Writer – Medical Devices, Combination Products

Location: Bilthoven

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)

Requirements

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.

Core Competencies
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.

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