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Technical Writer - Molecular Diagnostics (IFU Specialist)

Compass Consulting

Branchburg, NJ

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JOB DETAILS
SKILLS
Assays, Code of Federal Regulations, Cross-Functional, Document Management, Editing, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Medical Diagnosis, Medical Products, Microsoft Word, Molecular Analysis, Proofreading, Technical Writing
LOCATION
Branchburg, NJ
POSTED
30+ days ago
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.

About the Company

C

Compass Consulting

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