Technical Writer Medical Devices and Combination Products

Location: Bilthoven

Position Overview
We are seeking an experienced Technical Writer – R&D Design Controls to support the full design and development lifecycle, from early concept through verification, validation, and regulatory submission for class III medical devices and combination products.

This role is part of the R&D team and requires close collaboration with engineers, scientists, QA/RA, and clinical teams to ensure that design deliverables are technically sound, compliant, and fully traceable throughout the Design History File (DHF).

We are specifically looking for candidates with hands‑on experience supporting the design and development of high‑risk medical devices, preferably Class III implantable devices and/or combination products, who understand how design documentation evolves across development stages.

The ideal candidate is not only a strong writer, but also a design process contributor who understands design controls, risk management, human factors, and verification/validation activities, and can translate technical development work into compliant, high‑quality documentation.

Key Responsibilities
Design & Development Documentation

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 (per ISO 14971).

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.

Risk, Clinical & Regulatory Support

Develop and maintain technical, clinical, and biological evaluation documentation, including:

Clinical Evaluation Plans/Reports (CEP/CER)

Biological Evaluation Plans/Reports (BEP/BER)

Develop and contribute to the preparation of documentation specific to combination products to support early interactions with the FDA and other regulatory bodies, including:

Preliminary regulatory designations

Preliminary quality requirements

Pre‑submission packages

Early CMC roadmaps

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).

Contribute to continuous improvement of documentation practices, templates, and QMS processes.

Qualifications
Education

You have a technical or scientific degree (MSc or PhD) in chemistry, (medical) biology, biomedical technology, or similar.

Experience

Minimum 5 years of experience supporting medical device design and development documentation, preferably high‑risk medical devices, with a focus on Class III implantable devices and/or combination products.

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).

Skills

Knowledge of global Medical Device Regulations (EU MDR, FDA, TGA, etc.).

Knowledge of combination product development and associated submission deliverables.

Pragmatic, accurate, analytical, enjoying the dynamics of dealing with multiple stakeholders, business processes, regulatory and clinical challenges.

Strong organizational skills, detail‑oriented to manage multiple projects simultaneously.

Must be able to work well independently, as well as cooperate in a team of professionals.

Fluent in English, both verbally and in writing.

Legally able to work in The Netherlands.

Equal Employment Opportunity
Kuros Biosciences is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Kuros Biosciences complies with GDPR and the California Consumer Privacy Act (CCPA).

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