Technical Writer

PathAI-posted 11 days ago
Full-time • Mid Level
Remote • Boston, MA
101-250 employees
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PathAI is on a mission to improve patient outcomes with AI-powered pathology. We are transforming traditional pathology methods into powerful, new technologies. These innovations in pathology can help accelerate drug development, improve confidence in the accuracy of diagnosis, and get life-saving therapies to patients more quickly. At PathAI, you'll work with a diverse and talented team of people, who are dedicated to solving complex problems and making a huge impact. Where You Fit We're looking for a Technical Writer to join our operations team and lead the creation, maintenance, and globalization of our portfolio of products including our Image Management System (IMS), In Vitro Diagnostics (IVDs) and Companion Diagnostics.

  • Take ownership of managing all regulated, user-facing documentation for PathAI’s medical devices across our Digital Diagnostics (DDx), Translational Research (TxR), and Clinical Development Services departments.
  • Collaborate with cross-functional partners including Product, Engineering, Customer Success, Legal, Marketing, Regulatory and Clinical Affairs, and Quality.
  • Work closely with Engineering and Product teams to ensure technical accuracy and consistency between system behavior, design specifications, and documentation deliverables.
  • Support Regulatory and Quality teams during audits, submissions, and reviews by providing accurate, compliant documentation and traceability records.
  • Serve as the primary liaison between PathAI and external translation vendors, managing handoff, quality, timelines, budgetary quotes, and delivery of translated materials.
  • Translate technical documentation into user-facing training materials such as videos and self-service support articles.
  • Ensure documentation meets global regulatory and linguistic standards, including FDA, IVDR, and ISO requirements.
  • Leverage content reuse and single-sourcing strategies to build and maintain a structured knowledge base, enabling internal teams and customers to easily access accurate, consistent information.
  • 3+ years’ experience authoring and maintaining documentation such as Instructions for Use (IFU), product labeling, and release notes for medical devices, ideally Class II or III in the USA.
  • Experience working in a fast-paced Agile development environment, ideally on a Software as a Medical Device (SaMD) product.
  • Expertise in MadCap Flare or similar software to develop, manage, and re-use content in user documentation across multiple products.
  • Strong understanding of content reuse and single-sourcing principles using tools such as MadCap Flare, Confluence, Cursor, or Git-based systems.
  • A degree supporting technical systems communication (e.g., Engineering, Technical Writing, Technical Communications, Biomedical Science or related fields).
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