Technical Writer

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.