Technical Writer (IFU & Labeling)

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.

Responsibilities

• 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

• Associates Degree or equivalent level of education in a scientific discipline, technical writing, or other related technical field
• 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

Preferences

• Previous IFU knowledge

Benefits that Pride Health offers:

Pride Health offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.