Position Summary:
Supports product development teams by independently developing product instructional materials for complex medical devices or product lines. Deliverables may include product instructions for use, Quick Guides, online help, and other product-related customer-facing documentation and analysis of usability of these deliverables. Audience includes physicians, healthcare staff, facility engineers, and patients for a global audience. Deliverables must comply with medical device regulations, standards, and business requirements.
Essential Duties & Responsibilities:
Develop customer-facing product instructional information for an entire business unit according to user needs and regulatory requirements for domestic and international customers.Interface cross-functionally within the product development team to acquire source materials and to develop understanding of the products.Interview and collect information from Subject Matter Experts (SMEs) from R&D, RA, various functional areas.Write and edit Instructions For Use (IFUs), Quick Start Guides, and other accompanying documents aligning content with associated product labels.Participate in new product development meetings with cross-functional team members to capture inputs, project deliverables, and product specifications.Effectively plan and track workload and projects understanding the critical path and interdependencies in a multi-project environment while effectively communicating timelines with project teams.Manage multiple assignments for complex projects to meet project milestones.Collaborate with the Graphic Designer to incorporate graphical elements for instructional purposes and accurate interpretation and international application.Drive and assist with departmental continuous improvement endeavors.Review and edit the work of others prepared within the functional area.Train members of our functional team.Provide reviews of regulatory documentation to ensure that medical device labeling references are complete, correct, and compliant with FDA and EU requirements.Manage IFUs PLM/CMS system for controlled releases and revision management.Complete applicable QMS documentation as required by the regulatory and change management process.May own NCs/CAPAs as needed.May assist with regulatory audits.Participate and own improvement projects on the team.Qualifications & Experience:
2+ years applicable Technical Writing experience.Bachelor's degree required (English, Technical Writing, Technical Communication, Communication, or related curriculum preferred).Ability to work under pressure in a fast-paced environment.Able to apply fundamental and advanced concepts, practices, and procedures related to IFUs.Detail-oriented with the ability to manage multiple simultaneous projects while providing collaborative customer service.Strong organizational and time management practices.Able to prioritize and work within schedules.Must be able to understand and apply advanced technology applied to the technical area.Excellent problem-solving and analytical ability.Experience with a rigorous change management process.Interest in language translation and international communication.Understanding of the impact of language translation on format design.The ability to quickly learn new software.Preferred Experience: Previous work experience within a regulated industry or in an industry where attention to detail is required.Experience with Adobe Illustrator, XML, and enterprise CMS systems.
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