Technical Writer (IFU & Labeling)

We are seeking a detail-oriented Technical Writer (IFU & Labeling) to support the development and maintenance of Instructions for Use (IFU) and technical labeling documentation for molecular diagnostic products. This role will work closely with cross-functional teams to create clear, compliant, and user-friendly documentation in a regulated medical device/IVD environment.

Responsibilities

• Create, edit, and maintain IFUs and Quick Reference Guides (QRGs) for molecular diagnostic products
• Translate complex scientific and technical information into clear documentation for laboratory professionals and clinicians
• Perform detailed proofreading and editing to ensure accuracy, consistency, and compliance
• Manage documentation lifecycle within EDMS systems
• Collaborate with Regulatory, Quality, R&D, and cross-functional teams
• Support multilingual labeling and translation coordination activities
• Ensure compliance with FDA, IVDR, and ISO 13485 standards

Requirements

• 2–4 years of technical writing experience in Medical Device or IVD industry
• Experience with IFU and labeling documentation
• Strong proofreading and editing skills
• Advanced Microsoft Word and MS Office skills
• Familiarity with FDA, IVDR, and regulated documentation practices
• Associate Degree or equivalent required