Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies.
Overview:
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.
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.