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Job Description & How to Apply Below
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 (InDesign, 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
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