Job Description

Technical Documentation Specialist

Location: Branchburg NJ Type: Contract Compensation: $25-$28.17/hr Work Model: Hybrid – onsite and remote

Responsibilities

• Lead 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.
• 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.

Requirements

• Proficient in MS Office
• Strong proofing and editing skills
• Comfortable working independently through the IFU lifecycle
• High attention to detail and strong organizational skills
• 2-4 years of industry experience in Medical Device or In Vitro Diagnostics (IVD) technical writing of IFUs
• Familiarity with regulatory requirements (IVDR, FDA)
• Experienced in collaborating with cross-functional teams to meet project deadlines
• Ability to spot minor discrepancies in large, complex datasets
• Associates Degree or equivalent level of education in a scientific discipline, technical writing, or other related technical field

Job Tags

Similar Jobs