Biotech vacatures in Utrecht (provincie)

Technical Writer – R&D Design Controls (Medical Devices / Combination Products)

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.

Why Kuros Biosciences?

Join an international, innovative company with a diverse and energetic team. At Kuros, you’ll work in a positive and collaborative environment, contributing to the development of life-changing products. We offer great benefits, a competitive salary, and opportunities for career growth.

Our credentials

Kuros is a Swiss-headquartered biotech company, listed on the SIX Swiss Stock Exchange since 2016 (under symbol KURN). With additional operations in the Netherlands and the USA, we continue to grow our global team.

To deliver the ideal bone graft, you need the highest quality and quantity of scientific evidence behind it. We believe that this is a key differentiator for Kuros, given the urgent need to advance bone healing.

• Listing on the SIX Swiss Exchange under the symbol KURN since 2016
• A commercial & research footprint that spans >20 markets
• Dozens of clinical and scientific expert Advisers
• >25 orthobiologics-related patents
• >400 patients evaluated in Level I, randomized controlled clinical trials
• >20 well-controlled Level I-IV clinical trials initiated, including 6 that are complete1
• Published Level I evidence published in Spine

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). View our CCPA Notice here.