About This Role
This Technical Writer role supports the production of customer-facing product documentation, including user guides, service manuals, and instructions for use (IFUs) for medical device products within the Neuroscience portfolio. The role involves working on R&D projects, new product development, and maintaining released products, as well as ensuring labeling conforms to quality assurance standards and regulatory requirements.
Responsibilities
- Develop labeling products and associated documentation, including prototyping, editing, formatting, and coordinating reviews and approvals
- Collaborate with colleagues and cross-functional partners to ensure accuracy and quality of labeling content
- Manage multiple projects and priorities while meeting expected timelines
- Support the production of customer-facing product documentation, including user guides, service manuals, and instructions for use (IFUs)
- Work on R&D projects such as new product development and released products maintenance (e.g., sustaining activities and legacy document updates)
- Work on quality- and compliance-driven projects to ensure labeling conforms to quality assurance standards and labeling requirements from external standards and regulations (e.g., FDA, EU MDR, ISO, etc.)
- Be responsible for both the content in the labeling as well as the supporting documentation, which may include design plans, design input requirements and tracing documents, review documentation, and verification reports
- Investigate, document, and resolve labeling-related quality issues
- Manage all aspects of document development and assist in production release, including draft reviews and formal labeling approvals, coordination of translations, and initiating change order release
- Revise, edit, and format legacy product documentation as required, including user's guides, service manuals, instructions for providers (IFPs), and instructions for use (IFUs)
- Ensure compliance of labeling with all applicable regulatory/QSR requirements
- Create, edit, and format documentation as part of the compliance with requirements from the European Union (EU Medical Device Regulation)
- Deliver supporting documentation to the labeling product, including labeling design plans, trace documents, technical reviews and verification deliverables
- Effectively manage multiple projects, changes in project scope, and shifting priorities to maintain project requirements and ensure deadlines are met
- Collaborate with departmental and cross-functional peers to ensure proper resolution to questions and issues during the document development process
- Continually review the document development process to ensure quality in labeling output
Requirements
