Senior Technical Writer, Medical Device Labeling (Neurovascular)
About the role
We're looking for an experienced technical writer to create and manage labeling for neurovascular medical devices. You'll write Instructions for Use (IFUs), user guides, electronic labeling, and packaging artwork, and you'll take each one from first draft to final release. You'll work closely with R&D, Regulatory, Quality, Marketing, and Clinical teams.
What you'll do
Write, update, and improve IFUs, user guides, and electronic labeling
Create and edit packaging and label artwork in Adobe InDesign and Illustrator
Turn complex technical and regulatory information into clear content for clinicians and patients
Make sure labeling meets FDA, EU MDR, UDI, IMDRF, IEC 60601, ISO 20417, and ISO 15223 requirements
Lead change orders and keep review, verification, and traceability records
Support product launches and maintain existing documents
Keep up with regulatory changes and advise the team
What you need
6+ years of medical device experience in technical writing or labeling
Hands-on experience creating artwork in Adobe InDesign and Illustrator
Strong knowledge of IFU content requirements and labeling standards
Working knowledge of design controls and quality systems
Master's degree in a regulatory or engineering field
Nice to have
Neurovascular, cardiovascular, or class III device experience
Experience with content management systems and electronic labeling
