Senior Label Designer

Work Flexibility: Hybrid or Onsite ​ ​ Position Summary   ​ ​ 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 labe ls includes hospital and healthcare staff in global markets . Labels must comply with medical device regulations, standards, and business requirements. ​   ​ ​ Essential Duties & Responsibilities   ​   ​ 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 .   ​ U se 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 fo r 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, mergers and acquisitions, 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 .   ​ Initiate/assist with departmental continuous improvement endeavors.   ​ 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 .   ​ May assist with regulatory audits .   ​ Submit reports as requested by manager ​   ​ ​ Education   ​ ​ Bachelor’s Degree or relevant experience   ​ ​   ​ ​ Qualifications & Experience ​  ​ ​   ​ Previous work experience within a regulated industry .   ​ Able to apply fundamental and advanced concepts, practices, and procedures related to labels .   ​ Experience with a rigorous change management process .   ​ Detail orient ed with the ability to manage 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 technical area .   ​ Excellent problem solving and analytical ability .   ​ I nterest in language translation and international communication .   ​ Understanding of 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 .   ​ H ands-on e xperience with data base compilation labeling systems such as i.e., Prisym preferred .   ​ Experience with Adobe Illustrator and enterprise CMS system desirable.   ​ Experience with external service supplier s .   ​ E xperience with regulatory compliance for medical devices or pharmaceutical labeling .   ​ ​   #IJ        Ireland