Technical Writer Medical Devices

Technical Writer Medical Devices

• Standort: De Bilt, Niederlande
• Kontakt: Stefan Charles
• Jobtyp: Permanent
• Kontakt Telefon: +31 (0)20 406 97 50
• Branche: Life Sciences
• Kontakt-E-Mail: [email protected]

For an innovative medical technology company operating in a highly regulated environment, we are looking for an experienced Technical Writer to support the development of next-generation medical devices.
If you have a strong background in technical documentation within medical device development and enjoy working at the intersection of science, engineering and regulatory compliance, we would be interested in hearing from you.
Job description
This role is ideal for a professional who understands the complete product development lifecycle and enjoys translating complex technical and scientific information into clear, compliant documentation. You will work closely with multidisciplinary teams across R&D, Quality, Regulatory Affairs and Clinical functions, ensuring documentation supports both product development and regulatory approval activities.
Responsibilities

• Develop, review and maintain technical documentation throughout the full product development lifecycle.
• Support design control activities from early-stage development through verification, validation and regulatory submission.
• Contribute to Design History File (DHF) documentation and ensure traceability across development phases.
• Prepare and maintain risk management documentation in line with applicable standards.
• Support the creation of technical reports, clinical and biological evaluation documents, and regulatory submission packages.
• Collaborate with engineering, scientific, quality and regulatory teams to ensure documentation accurately reflects product development activities.
• Participate in design reviews and documentation improvement initiatives.
• Support documentation requirements for global regulatory submissions.

Requirements

• Essential minimum 5 years of experience as a Technical Writer within the medical device industry.
• Proven experience supporting R&D and product development activities for medical devices.
• Strong understanding of design controls, risk management, verification and validation documentation.
• Experience supporting products through the journey from development to regulatory registration and market approval.
• Excellent written English communication skills.
• Ability to work effectively with cross-functional stakeholders.
• Highly Desirable
• Experience with higher-risk or complex medical devices.
• Knowledge of global regulatory frameworks including EU MDR and FDA requirements.
• Experience contributing to technical documentation used in regulatory submissions.

Additional Information

• Medical Devices R&D experience is mandatory.
• Dutch language skills are not required.
• Hybrid working model with up to 3 days working from home per week.
• Competitive salary of up to €75,000 annually, depending on experience.
• Opportunity to play a key role in bringing innovative healthcare technologies from concept through to regulatory approval and commercialization.

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