Senior Label Designer

• Support multiple concurrent labeling projects for new products, mergers and acquisitions, and label maintenance
• Participate in new product label planning meetings and capture requirements using quality system planning documents.
• 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.
• Inform Business Units on relevant aspects of the labelling process such as requirements, costs, and timelines.
• Design label formats for functional usability by healthcare staff
• Use specialised labeling software to generate templates and enter label data, text, and graphics into label database for print-on-demand label system. Perform troubleshooting of electronic files as needed.
• 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
• Ensure labels including translations are executed in an efficient and timely manner through collaboration with an external translation service.
• Review labels and IFUs for completeness and presentation including labels created by others
• As needed, engage in support activities related to publication of IFUs to eIFU website
• Review of regulatory documents to ensure medical device labelling references are correct
• Initiate/assist with departmental continuous improvement endeavours.
• Track data/metrics associated with functional area.
• May assist with internal and external regulatory audits.
• Contact external suppliers to resolve label output details.
• Manage work to meet project milestones.
• Inform project managers of relevant aspects of language translation and impact to label design.
• 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
• Submit reports as requested by manager​

• Bachelor’s Degree in Communications, Data Management, Procurement, General Business Management, Regulatory Sciences, or equivalent is required and 3 years equivalent experience in the medical device, pharmaceutical or other highly regulated industry.
• Experience with a rigorous change management process
• Detail oriented 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
• Interest 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
• Hands-on experience with database compilation labeling systems such as i.e., Prisym preferred
• Experience with Adobe Illustrator and enterprise CMS system desirable.
• Experience with external service suppliers
• ​Experience with regulatory compliance for medical devices or pharmaceutical labeling
• Excellent written and verbal English communication; knowledge of non-English language could be an asset but is not required

Stryker