Technical Writer
Kelly is hiring a Technical Writer for one of our clients in Branchburg, NJJob Title: Technical Writer (IFU & Labeling)Working Model: Hybrid (3 days on site, 2 days remote)Working Days: M-F 1st shiftWorking Hours: 0800-1630Interview Model: Two rounds total – virtualKey Skills Required: MS Office, Proofing, previous IFU knowledge preferred.Education Requirements: Min. Associates Degree or equivalentPay: negotiable Job descriptionLead the end-to-end development, writing, and rigorous editing of Instructions for Use (IFU) and technical labeling for complex molecular diagnostic assays. Translate complex scientific data into clear, compliant, and user-friendly documentation for laboratory professionals and clinicians.Key responsibilities include:Creating and revising IFUs and Quick Reference Guides (QRGs) for molecular diagnostic products.Utilizing advanced Microsoft Word skills for complex document structures (nested numbering, cross-references, tables, multi-language layouts).Performing meticulous proofreading to ensure accuracy in scientific terminology, unit conversions, and symbol usage; adhering to ISO 13485, FDA 21 CFR Part 820, and IVDR.Managing full document lifecycle within an Electronic Document Management System (EDMS).Partnering with cross-functional stakeholders to gather content and ensure alignment.Managing translations of IFUs and labeling as needed.Who You AreProficient in MS OfficeStrong proofing and editing skillsComfortable working independently through the IFU lifecycleHigh attention to detail and strong organizational skills2–4 years of industry experience in Medical Device or In Vitro Diagnostics (IVD) technical writing of IFUsFamiliarity with regulatory requirements (IVDR, FDA)Experienced in collaborating with cross-functional teams to meet project deadlinesAbility to spot minor discrepancies in large, complex datasetsPreferred (Optional)Previous IFU knowledgeAssociates Degree or equivalent level of education in a scientific discipline, technical writing, or other related technical field