12 month contract with full Stryker benefits.What you will do:ResponsibilitiesAs a member of the Technical Publications team, create and revise product labels to meet labeling requirements for medical devices. Collaborates with product subject matter experts to gather and assess labeling content. Executes label format and compiles content using specialized softwareThis is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. The job requires attention to detail in making evaluative judgements based on the analysis of factual informationCollaborate with product SMEs to assess and determine label requirements and content: Regulatory Affairs, Product Development, Product Safety Engineering, Packaging Engineers, Clinical Sciences, Marketing, Trade Compliance, etc.Participate in new product label planning meetings and capture requirements using quality system planning documents.Design label formats for functional usability by healthcare staffUse specialized labeling software to generate templates and enter label data, text, and graphics into label database for print-on-demand label systemUse desktop publishing software to design labels produced by external suppliersEnsure barcodes pass verification testingSelect appropriate label materials for labels applied to packages and products in collaboration with packaging engineersAs needed, support label translation strategies that satisfy international labeling needsSupport multiple concurrent labeling projects for new products, mergers and acquisitions, and label maintenanceReview labels for completeness and presentation including labels created by othersContact external suppliers to resolve label output detailsManage labels in PLM/CMS system for controlled label releases and revision managementManage work to meet project milestonesInform project managers of relevant aspects of language translation and impact to label designCommunicate impact of language translation for alignment with project timelines and costInitiate, drive and assist with departmental continuous improvement endeavorsCollect and track data/metrics associated with projectsProvide reviews of regulatory documentation to ensure that medical device labeling references are complete and correct and compliant with FDA and EU requirementsMay assist with regulatory auditsWhat you will need:Bachelors Degree in Communications, Data Management, Procurement, General Business Management, Regulatory Sciences, or equivalent is required. (Level 8)Experience working with/entering data into data-driven softwarePreferred experience navigating challenges related to language translation and Excel
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