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Technical Writer – Medical Devices, Combination Products
Kuros BiosciencesTechnical Writer for R&D Design Controls supporting the design and development of class III medical devices and combination products. Collaborating with engineers and healthcare professionals to ensure documentation compliance.
Posted 7/10/2026full-timeBilthoven • 🇳🇱 NetherlandsMid-LevelSenior💰 €5,100 - €5,600 per monthWebsite
Core Competencies
Role fitCore Competencies
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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.
Highest-signal resume keywords
Class III Medical Device DevelopmentDesign Control DocumentationRegulatory Submissions (EU MDR, FDA)Risk Management (ISO 14971)Technical Documentation Development
ATS Keywords
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Hard Skills
Design History File (DHF) ManagementVerification and Validation (V&V)Risk Management DocumentationHuman Factors DocumentationSystematic Literature ReviewsInstructions for Use (IFUs) DevelopmentBiological Evaluation DocumentationCombination Product DevelopmentRegulatory ComplianceTechnical Writing
Soft Skills
Strong Organizational SkillsDetail-OrientedAnalytical ThinkingTeam CollaborationStakeholder Engagement
Industry Keywords
Medical Device RegulationsCombination ProductsRegulatory BodiesClinical EvaluationQuality System Requirements
About the role
Key responsibilities & impact- 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
What you’ll need- 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.
Benefits
Comp & perks- Great benefits
- Opportunities for career growth