Description: Write and manage IFUs for CATD products. Gather input from Engineering, Marketing, Clinical, and Regulatory, etc., to define specific requirements for IFUs by attending project meetings and meeting with individual experts as necessary. Enhance professional appearance and readability of product IFUs by editing them for grammar, consistency, style, and format. Coordinate final IFU implementation to ensure that all requirements and deadlines are met (including translation, freelance graphic designer, documentation release, and print vendors, etc.). Produce IFU content by following defined requirements, using the following prescribed software FrameMaker, InDesign. Note Technical writing experience in a medical\/pharma device industry. Manager want technical writer candidates with prior experience writing IFUs (Instructions for Use) for end-users, i.e., clinicians and\/or patients. Manager is looking for folks with a minimum of 3 years of prior experience but preferably more years of experience. Looking for Technical Writers who have experience in the medical device industry with prior experience creating IFUs. Manager need someone who understands FDA and EU medical device labeling regulations; that is, someone who has experience creating these types of documents. Someone who has knowledge\/experience in FDA, ISO, TuV, and 21CFR Part11 regulations related to medical device labeling.
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ICONMA is a nationwide consulting firm with corporate headquarters in Troy, MI, providing Professional Staffing and Project Based Services and Solutions for Fortune 1000 clients in a broad range of industries. Core Industries served include: Biotech/Pharmaceutical, Cable, Clinical, Consumer Services, Energy, Engineering, Financial Services, Food & Beverage, Government/Defense, Healthcare, Insurance, Logistics, Manufacturing, Media, Mortgage, Oil & Gas, Pharmaceutical, Retail, Scientific, Services, Technology, Telecommunications, Transportation, and Utilities. ICONMA is a certified Woman-Owned “Woman-Owned Business Enterprise”, certified by Women’s Business Enterprise National Council (WBENC) and National Women Business Owners Corporation (NWBOC).