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Fremont

    Labelling and Documentation Specialist - Fremont, United States - Comrise

    Comrise
    Comrise Fremont, United States

    4 weeks ago

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    Description

    Labelling and Documentation Specialist - 12 month contract - Fremont, CA

    Opportunity with a leading Medical Device company

    As part of Sustaining R&D, the Lead Analyst, R&D Technical Writing is responsible for creating end-user regulatory complaint product labeling. The specialist contributes to new product development and design change (sustaining) activities in the areas of labeling design/release, technical writing, translation management, development of artwork/images and development or improvement of processes for improved efficiency and compliance. This role will engage with cross functional teams to resolve obstacles effectively, be responsible for meeting key labeling objectives, and lead/collaborate on continuous improvement initiatives or special activities having business impact.

    General Requirements:


    • 4-6 years of relevant experience in developing or delivery of technical publications that are part of products including writing, graphic design, development of artwork/images, document control, related to engineering, with part of experience in a medical device/regulated industry:


    • Bachelor's Degree in Graphics or Language or equivalent experience (Advanced degree may be considered towards years of experience)


    • Required to have a high level of service and responsibility in managing highly detailed and varied workload from internal customers and be comfortable working to tight timelines


    • Provide weekly summary of activities, create project plans, prioritize, and effectively communicate updates to customers


    • Follow Good Document practices (GDP) for all documentation created/reviewed and staying current on all required training for incumbent position


    • Subject Matter Expert (SME) in Microsoft Applications (Word, Excel, PowerPoint, and Visio), Adobe Suite (InDesign, FrameMaker, Photoshop, and Illustrator)


    • Demonstrated experience in the following: Instructions for Use, Training Guides, Support of Electronic IFU (eIFU) and website, Translation management

    Required Software:


    • Microsoft applications (Word, Excel, PowerPoint, and Visio)


    • Adobe Suite (InDesign, Frame Maker, Photo Shop, and Illustrator)


    • Experience in website design and testing

    Nice to have Software:


    • For Label Designer Role: Database driven labeling system such as Prisym ID, Label View, Loftware, Bartender Nice Label, and Easy Label, Computer Aided Drafting (CAD) – Solidworks, AutoCAD

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