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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.
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 on the work of others prepared work within functional area.
* Train members of our functional team.
* Provide reviews of regulatory documentation to ensure that medical device labeling references are complete and 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 technical area.
* Excellent problem solving and analytical ability.
* Experience with a rigorous change management process.
* Interest in language translation and international communication.
* Understanding of impact of language translation to 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 system.
Travel Percentage: 10%
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