Title: Staff Labeling Specialist
Duration: 18+ Months contract
Description :
• Under minimal supervision, develops and maintains labels for medical devices.
• Collaborates with product subject matter experts to gather and assess labeling content.
• Executes label format and compiles content using specialized software.
• Audience for labels includes hospital and healthcare staff in global markets.
• Labels must comply with medical device regulations, standards, and business requirements.
Additional Job Details :
• Collaborate 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 staff
• Use specialized labeling software to generate templates and enter label data, text, and graphics into label database for print-on-demand label system
• Use desktop publishing software to design labels produced by external suppliers
• Ensure barcodes pass verification testing
• Select appropriate label materials for labels applied to packages and products in collaboration with packaging engineers
• As needed, support label translation strategies that satisfy international labeling needs
• Support multiple concurrent labeling projects for new products and label maintenance
• Review labels for completeness and presentation including labels created by others
• Contact external suppliers to resolve label output details.
• Manage labels in PLM/CMS system for controlled label releases and revision management.
• Manage work to meet project milestones.
• Inform project managers of relevant aspects of language translation and impact to label design.
• Communicate impact of language translation for alignment with project timelines and cost
• Collect and track data/metrics associated with projects
• Provide reviews of regulatory documentation to ensure that medical device labeling references are complete and correct and compliant with FDA and EU requirements
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