Technical Writer - Molecular Diagnostics (IFU & Labeling)

Role Overview

The Technical Writer is responsible for the end-to-end development, writing, and rigorous editing of Instructions for Use (IFU) and technical labeling for complex molecular diagnostic assays.

This role focuses on translating complex scientific data into clear, compliant, and user-friendly documentation for laboratory professionals and clinicians, ensuring that every document meets strict global regulatory standards (e.g., IVDR, FDA). The technical writer may also be responsible for managing translations of IFUs and labeling.

Key Responsibilities

IFU Development

• Lead the creation and revision of Instructions for Use (IFUs) and Quick Reference Guides (QRGs) for molecular diagnostic products.

Expert Document Formatting

• Utilize extensive and deep Microsoft Word expertise to manage complex document structures, including nested numbering, cross-references, integrated tables, and multi-language layouts.

Regulatory Compliance & Proofreading

• Perform meticulous proofreading and technical editing to ensure 100% accuracy in scientific terminology, unit conversions, and symbol usage.
• Ensure all documentation adheres to ISO 13485, FDA 21 CFR Part 820, and IVDR requirements.

EDMS Management

• Manage the full document lifecycle within an Electronic Document Management System (EDMS), overseeing workflows for drafting, review, approval, and archival.

Cross-Functional Collaboration

• Partner with key stakeholders to collect content and ensure team alignment.

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.

Required Skills & Qualification:

• The candidate shall be proficient in using eDMS and Microsoft Office, and is comfortable working through the IFU lifecycle independently.
• A high attention to detail and organizational skills is required.

Preferred (Optional):

• Associates Degree or Equivalent level of education in a scientific discipline, technical writing, or other related technical field.
• 2-4 years of industry experience in Medical Device or In Vitro Diagnostics (IVD) Technical Writing of IFUs and a familiarity with regulatory requirements.
• Experienced in collaborating with cross-functional teams to meet project deadlines.
• Experience with Electronic Content Management Systems and Microsoft Office.
• Attention to detail, with an extreme focus on consistency, grammar, and scientific accuracy; ability to spot minor discrepancies in large, complex datasets.