Technical/Functional Skills - Proficient with FrameMaker® software, proficient with Adobe Acrobat® and PhotoShop® software, vector graphics software (e.g. Adobe Illustrator® or CoreDraw) and HTML
Experience Required - Preferable experience in the medical or scientific software field. Experience with Structured Authoring using XML and content management solutions. Experience writing for a global audience. Experience with professional translation services. Experience with formal quality systems and design controls for medical devices, including requirements, verification, and validation testing
Roles & Responsibilities - Identify IFU requirements and obtain necessary raw information from various sources. Learn and understand the design and behavior of the company's products. Design, develop, and maintain IFU using FrameMaker® and other software applications. Control IFU versioning and maintain the IFU archives. Provide IFU-related support to the Marketing, Product Development, and Regulatory groups. Identify IFU translation requirements, prepare and manage translation projects to completion. Perform the administrative documentation tasks required to establish and track IFU in a Product Lifecycle Management system. Continuously evaluate business processes, identify improvement opportunities, and implement improvements. Proofread and edit the work of other writers. All activities must be performed in compliance with the Quality System. Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations. All other duties as assigned. Travel requirement: Less than 10%
Education - BS / BA English, Communications, or Journalism or a related degree.
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