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 .</sp