Engineering - Prin Technical Writer

Job Title: Prin Technical Writer
Job ID: 28394
Location: 5290 California Ave, Irvine California 92617
Duration: 24 months
Pay rate: 60-65.00/hr on w2

Must-Have Requirements

• 6+ years of medical-device technical writing/labeling experience.
• Strong experience creating labeling/artwork files using Adobe Illustrator and Adobe InDesign.
• Expert knowledge of Instructions for Use (IFU) and medical-device labeling content requirements.
• Strong knowledge of labeling standards and regulations.
• Experience with FDA, EU MDR, IMDRF, UDI, IEC 60601, ISO 20417, and ISO 15223.
• Experience supporting new product development and sustaining/legacy medical-device labeling.
• Experience with design controls, change orders/change control, traceability, verification, review and approval workflows.
• Strong technical writing, editing, content development, and document lifecycle management skills.
• Ability to work cross-functionally with R&D, Regulatory, Quality, Clinical, Medical Safety, Marketing, and Engineering.
• Master’s degree in Regulatory Affairs or Engineering required.
• 5+ years with advanced degree / 7+ years with bachelor’s degree; HM preference is 6+ years medical-device labeling experience.