Adobe FrameMaker, Adobe InDesign, Cross-Functional, Documentation, Maintain Compliance, Marketing, Medical Equipment, Presentation/Verbal Skills, Product Lifecycle Management, Project/Program Management, Quality Engineering, Quality Management, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Technical Writing, Writing Skills, XML Tools
Technical Writer (Job ID: 26692)
Location: North Haven, CT (Onsite 4 days/week, 1 day remote)
Duration: 12 Months
Pay Rate: $50–55/hr
Experience: 5–10 Years
Must-Have Skills
- Technical writing/documentation experience in regulated industries
- Strong written/verbal communication and cross-functional collaboration
- Experience with authoring tools (InDesign, FrameMaker, XML tools)
- Medical device labeling or regulated documentation experience
- Quality Management System (QMS) and compliance knowledge
Key Responsibilities
- Develop, update, and manage medical device labeling/Instructions for Use (IFU)
- Incorporate feedback from Regulatory, Quality, Engineering, and Marketing teams
- Manage labeling projects, approvals, and launch activities
- Coordinate translations and track deliverables
- Support PLM workflows, ECO processes, and documentation approvals
- Review proofs and support regulatory submissions
- Participate in project meetings and collaborate across functions
- Ensure compliance with quality and regulatory requirements