Senior Label Designer

​​Position Summary 

​​Underminimal supervision, develops andmaintains labels formedicaldevices.Collaborateswith productsubject matter experts togather and assess labeling content.Executeslabel formatandcompilescontentusing specialized software.Audience for labels includes hospital and healthcare staff in global markets.Labels mustcomply withmedical deviceregulations,standards, and business requirements.​ 

​​Essential Duties & Responsibilities 

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• ​Collaborate with product SMEs toassess anddetermine label requirements and content: Regulatory Affairs, Product Development,ProductSafety 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 intolabel database forprint-on-demand label system. 

• ​Use desktop publishing software to design labels produced by external suppliers. 

• ​Ensure barcodes pass verification testing. 

• ​Selectappropriate label materials for labels applied to packages and productsin collaboration with packaging engineers. 

• ​As needed, support label translation strategies that satisfy international labeling needs. 

• ​Support multipleconcurrent labeling projects for new products, mergers and acquisitions, and label maintenance. 

• ​Review labels for completeness andpresentation 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 translationandimpact to label design. 

• ​Communicateimpact of language translation for alignment with project timelines and cost. 

• ​Initiate/assist with departmental continuous improvement endeavors. 

• ​Collect and track data/metrics associated with projects. 

• ​Provide reviews of regulatorydocumentation to ensurethatmedical device labeling references are complete and correct and compliant with FDA and EU requirements. 

• ​Mayassist with regulatory audits. 

• ​Submit reports as requested by manager​ 

​​Education 

• ​​Bachelor’s Degreeor relevantexperience 

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​​Qualifications & Experience​ ​​ 

• ​Previouswork experience within a regulated industry. 

• ​Able to apply fundamental and advanced concepts, practices, and procedures related to labels. 

• ​Experience witharigorous change managementprocess. 

• ​Detail oriented with the ability tomanage multiple simultaneous projects. 

• ​Strong organizational and time management practices. 

• ​Able to prioritize and work within schedules. 

• ​Must be able to understand and apply advanced technology applied to technicalarea. 

• ​Excellent problem solving and analytical ability. 

• ​Interest in language translation and international communication. 

• ​Understandingof impact of language translation to format design. 

• ​Ability to work under pressure in a sometimes fast‐paced environment. 

• ​Highly developed computer skills and able to quickly learn new software. 

• ​Experience working with/entering data into data-driven software. 

• ​Hands-onexperience withdatabase compilation labeling systems such asi.e.,Prisym preferred. 

• ​Experience withAdobe Illustrator and enterprise CMS systemdesirable. 

• ​Experience with external service suppliers. 

• ​Experience with regulatory compliance for medical devices or pharmaceutical labeling. 

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