Cross-Functional, Document Management, Documentation, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Maintain Compliance, Medical Equipment, Medical Writing, Multitasking, Presentation/Verbal Skills, Product Development, Product Support, Project Planning, Project/Program Management, Quality System Requirements (QSR), Regulations, Research & Development (R&D), Strategic Planning, Support Documentation, Technical Writing, Time Management, Writing Skills
Job Title: Sr Technical Writer
Job ID: 26944
Location: 7000 Central Ave NE Minneapolis Minnesota 55432
Duration: 12 months
Pay Rate: $50.00 - $55.00/hr. on W2
Role Summary
Seeking an experienced Senior Technical Writer to develop and manage medical device labeling documentation for an ablation product line. Responsible for IFUs, user manuals, package labels, device labels, and supporting regulatory documentation. Must be highly independent, self-driven, and able to manage multiple projects with minimal supervision.
Must-Have Skills
- Technical Writing (medical device documentation preferred)
- Project Management
- Strong written/verbal communication
- Self-driven, independent, and accountable
Required Experience
- 4+ years of technical writing experience (2+ with advanced degree)
- Medical device labeling experience:
- IFUs (Instructions for Use)
- User Manuals
- Device & Package Labels
- Experience supporting FDA, EU MDR, ISO, and Quality System requirements
- Cross-functional collaboration with R&D, Quality, Regulatory, and SMEs
Key Responsibilities
- Create and maintain product labeling and supporting documentation
- Develop labeling strategies and project plans
- Ensure compliance with FDA, EU MDR, ISO, and QMS requirements
- Write, edit, review, and release technical documentation
- Manage multiple documentation projects and deadlines
- Communicate project status, risks, and timelines to stakeholders
- Support both new product development and sustaining projects