New

Technical Writer

Fresenius Kabi USA, LLC
$70,000-80,000
life insurance, 401(k)
United States, Illinois, Lake Zurich
3 Corporate Drive (Show on map)
Nov 13, 2025
Job Summary Technical Writers in the MedTech Labeling Team manage the design, creation, and implementation of product and technical documentation. Their work supports product registrations, quality initiatives, business operations, and regulatory compliance. Deliverables include operator manuals, software release notes, administrator guides, quick reference guides, and other regulated materials for medical devices. They author and maintain labeling artwork and components using designated management systems, ensuring alignment with procedures and style/design guides. The role oversees labeling projects from initiation through approval, maintaining version control and ensuring alignment of timelines and resources. Writers actively participate in cross-functional initiatives and product teams to enhance labeling processes, tools, and deliverables. The MedTech Labeling Team's scope includes global labeling strategies, harmonization of processes, content management, global product data and electronic instructions for use (eIFU) initiatives. This position requires working onsite in Lake Zurich, IL 3 days per week; remaining days may be worked remotely. Salary Range: $70,000-80,000 Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Responsibilities This role manages and supports the efforts of team members, cross-functional stakeholders, and labeling related service suppliers to deliver project deliverables per commitments. Specific activities may include, but are not limited to: Author and revise information for use (e.g. operator's manuals, supplements, technical documentation, user guides, addendums, product inserts, packaging, and other types of labeling) Translate complex technical information into clear, user-friendly content; create visual aids such as charts, flow diagrams, illustrations and/or screenshots as needed. Represent Labeling cross-functionally with Engineering, Clinical Education, Regulatory, Marketing, Manufacturing and Quality teams to gather source content and manage review cycles throughout a project or product development process. Maintain version control, labeling projects and approvals through the end-to-end labeling platform. Upload content and maintain metadata within the content management system. Ensure smooth start of activities, alignment of timelines and expectations at the start of labeling projects in order to re-establish and prioritize resources. Requires communication across stakeholders regarding challenges, changes in execution status, timelines, priorities, etc. Ensure compliance with internal style guides, applicable harmonized (ISO/IEC) standards, and global UDI requirements for medical devices. Use comparison tools and checklists to verify changes made to label artwork and translations as needed. Support and maintain global labeling templates and symbol glossary for use across products. Perform or support administrative tasks related to global labeling platforms, including eIFU distribution, global product data and end-to-end labeling systems. As part of Labeling Team, this role has shared responsibility and accountability for ensuring the Quality, global compliance and business process requirements are met across end-to-end labeling activities (including Global UDI) and that labeling related activities and related objectives are compatible with the strategic direction of the organization. All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities. Job Requirements Bachelor's degree required. Preference for a bachelor's degree in English, Technical Writing, Technical Communications, Graphic Design / Art, Creative Writing Proficient in Adobe Creative Suite (Adobe Pro, InDesign, Illustrator...) Ability to distill complex process content, requirements, challenges etc. to brief, concise, and understandable language with creativity and increasing independence Ability to manage concurrent projects and priorities, respect project schedules and effectively communicate project status and activities to stakeholders. Knowledge of FDA, MDR, ISO Standards, GS1 Standards and other global industry regulations and standards related to labeling, barcoding, symbols, eIFU, for medical devices. Knowledge of medical device regulated environments, including GDP, GLP, GMP, and regulated Quality Systems Strong interpersonal skills, including effective verbal and written communication and negotiating skills. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Project, Visio) Preferred experience with content management systems, metadata management Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.