Technical Writer (Medical Devices)
About the RoleWe are seeking a Technical Writer to join our team in the medical device industry. In this role, you will be responsible for creating, maintaining and publishing high-quality user documentation that meets regulatory requirements and supports safe and effective product use.You will work closely with cross-functional teams including R&D, Regulatory Affairs and Product Management to ensure documentation accuracy, compliance and usability.ResponsibilitiesWrite, edit and update user manuals and technical documentation for medical devices in accordance with applicable regulations, ensuring clarity, consistency, user focus, and alignment with usability and risk management requirements.Gather and structure information from Subject Matter Experts (SMEs), engineering documentation, risk files and project materials.Develop and maintain reusable content within the CCMS by applying structured authoring principles, including topic-based and modular information design, to enable scalable single-source publishing across multiple products, variants, and markets.Manage the documentation lifecycle, including version control, change management and full document traceability within a regulated environment.Coordinate and manage localization processes, including communication with external translation agencies and review of translated content.Prepare and publish user documentation for online distribution and ensure availability and compliance on the company website.Support audits and regulatory submissions by providing required documentation and evidence of compliance.RequirementsBachelor's or Master's degree in Humanities, Engineering or a related STEM field.At least 2 years of professional experience in technical writing, ideally in a regulated environment.Fluent written and spoken English (additional languages are a plus).Experience working with a Component Content Management System (CCMS), ideally Paligo.Understanding of structured authoring methodologies, including topic-based writing, modular documentation strategies and single-source publishing.Excellent written communication skills with a strong focus on clarity, consistency and user readability.Ability to collaborate effectively with cross-functional teams.Nice to haveExperience in the medical device industry.Familiarity with regulatory frameworks (e.g., MDR, ISO 13485, FDA).Knowledge of Adobe Creative Suite (e.g., Illustrator, InDesign) for handling graphics and layout.