Medical Device Technical Writer – (Contract) - Remote - 6 months w/likely extension - EST/CST hours
Medical Device organization seeks a Medical Device Technical Writer with 3+ years experience writing Medical Device/IVD end-user documentation, like IFU/User Manuals/Package Inserts. Additionally, this person must have expertise in MadCap Flare, FDA/ISO-regulated documentation and Quality Management Systems. Ideally this individual will also have Desktop Publishing (MS Office + Adobe FrameMaker). Opportunity offers a long-term contract with likely extensions and the possibility to go permanent if individual should desire.

Benefits

• Pay Range: $35–$50/hr W2 
• Work Arrangement: Remote
• Duration: 6 months (contract-to-hire / potential conversion to salary; salary range noted $80K–$98K)

Responsibilities
       Documentation Development & Lifecycle Management

• Create, revise, route for review/approval, and maintain technical documentation; ensure consistency across assigned product/document sets.
• Develop end-user medical device documentation such as Instructions for Use (IFUs), user manuals, package inserts, appendices, and quick reference guides.
• Translate product requirements, customer needs, and internal processes into clear documentation requirements and deliverables.

       Tools, Publishing & Content Reuse (MadCap Flare)

• Author and manage content in MadCap Flare (required), leveraging variables, conditional text/tags, snippets, and reuse strategies to support consistent outputs (primarily PDF).
• Use desktop publishing tools effectively (Microsoft Office suite and Adobe FrameMaker required).

       Cross-Functional Collaboration & Project Execution

• Partner with cross-functional stakeholders (e.g., Engineering, Quality, Regulatory, Marketing) to align documentation with product use, labeling expectations, and design/control deliverables.
• Contribute to project planning and documentation strategy to meet milestones; balance speed vs. quality and propose practical process improvements.
• Provide proactive communication, status updates, and issue/risk escalation; support troubleshooting/problem-solving for complex documentation challenges.

Required Qualifications

• Bachelor’s degree (or higher).
• A consultant willing to be paid as W2 employee hourly.
• 3+ years of technical writing experience in life sciences, specifically IVD/medical devices.
• Demonstrated experience producing true end-user documentation for medical devices (not SOPs, work instructions, reports, etc.).
• Working knowledge of medical device documentation expectations within regulated environments (FDA/ISO/QMS).
• MadCap Flare expertise is a must.
• Advanced proficiency with desktop publishing tools: Microsoft Office Suite and Adobe FrameMaker.
• Strong writing/editing skills (grammar, punctuation) and stakeholder communication skills.

Preferred Qualifications

• Prior experience working directly for a medical device company.
• Writing samples created in MadCap Flare (strong plus).
• Clear understanding of medical devices vs. IVD and how that impacts labeling/user documentation.