Technical Writer (Medical Devices)
About the Role
We 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.
Responsibilities
* Write, 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.
Requirements
* Bachelor’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 have
* Experience 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.