Technical Writer for Medical Devices

Job Summary

Supporting the Product Development team, the full-time remote Technical Writer for Medical Devices will author and edit high-quality technical documents for FDA regulatory submissions and internal design-control activities, collaborating with cross-functional teams to ensure clarity and compliance.

Key responsibilities

• Draft, edit, and maintain FDA-facing technical documents, including Pre-Sub/Q-Sub packages and meeting materials
• Collaborate with subject matter experts to gather inputs for submission-ready documents and ensure alignment across various sections
• Manage document review cycles, reconcile feedback, and maintain accurate revision history within the quality management system

Required qualifications

• Master's or Ph.D. in Life Sciences, Biomedical Sciences, Biomedical Engineering, or a relevant field
• 3-5 years of technical writing experience in regulated medical devices or IVDs, with a strong focus on FDA documentation
• Demonstrated experience preparing FDA-facing documents as part of a cross-functional team
• Strong command of scientific writing and ability to synthesize complex content into clear documents
• Experience with controlled documents in a quality management system environment