Technical Writer Medical Devices and Combination Products

Technical Writer Medical Devices and Combination Products

Kuros Biosciences

Bilthoven, Netherlands

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 for 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 Ph.D.) 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, 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).

Skills:

• 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.