Technical Writer Molecular Diagnostics (IFU Specialist)

Job Description:

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.

Who You Are:

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 Preferred (Optional): Previous IFU knowledge Associates Degree or equivalent level of education in a scientific discipline, technical writing, or other related technical field Pay ranges between 20-28/hr based on experience