01 ago
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Cosmed - The Metabolic
|
Roma
01 ago
Cosmed - The Metabolic
Roma
We are looking for a proactive, precise, and strong communicator to join our team as a Technical Writer in the medical device field. In this role, you will be responsible for delivering high-quality, compliant user documentation that supports the safe and effective use of our products and meets strict regulatory requirements. You’ll work at the intersection of engineering, regulatory, and product, transforming complex information into clear, structured, and user-focused content. What You’ll Do Create, update, and manage user manuals and technical documentation in accordance with applicable regulations Ensure documentation is clear, consistent, and aligned with usability and risk management requirements Collaborate closely with R&D;, Regulatory Affairs, and Product Management Gather and structure information from SMEs, engineering documents, and risk files Contribute to structured authoring and CCMS-based documentation (modular, topic-based, single-source) Manage the full documentation lifecycle: versioning, change control,
and traceability Coordinate localization processes with external translation partners Prepare and publish documentation for digital distribution Support audits and regulatory submissions What We’re Looking For Bachelor’s or Master’s degree in Humanities, Engineering, or a related STEM field At least 2 years of experience in technical writing (ideally within a regulated environment) Fluent written and spoken English (additional languages are a plus) Excellent communication skills: clear, structured, and precise writing is essential Strong ability to work cross-functionally and proactively gather information Experience with a CCMS (Paligo is a plus) Solid understanding of structured authoring methodologies (topic-based writing, modular content, single-source publishing) Mandatory Technical Skills Advanced proficiency in Microsoft Office (Word & Excel) — essential for authoring, formatting, and document management Working knowledge of Adobe tools (In Design, PDF suite) for layout, publishing, and final document preparation Experience in the medical device industry Familiarity with regulatory frameworks (MDR, ISO 13485, FDA) Knowledge of Adobe Illustrator or similar tools for graphics #J-18808-Ljbffr
📌 Technical writer (medical devices) (Roma)
🏢 Cosmed - The Metabolic
📍 Roma