Senior Label Designer

Stryker; Cork; On-site; EUR 49,000 - 82,000; Full time

Job summary

Stryker Ireland is seeking a labeling specialist to develop and maintain medical device labels for global markets. You will collaborate with Regulatory Affairs, Product Development and Packaging teams to ensure compliant label content and formats.

Work with labeling software and CMS systems, manage translation considerations, and support multiple labeling projects related to product launches and label maintenance. Strong regulatory knowledge and detail orientation are essential.

Qualifications

• Experience in a regulated industry or medical device/pharma labeling.
• Understanding of FDA/EU labeling requirements is advantageous.
• Strong attention to detail with ability to manage multiple projects.

Responsibilities

• Collaborate with product SMEs to determine label content and requirements.
• Design label formats for usability by healthcare staff.
• Use labeling software to create templates and enter data for print-on-demand systems.
• Ensure barcodes pass verification testing and verify translation impact on design.

Skills

Labeling systems

Regulatory compliance

Change management

Project management

Detail oriented

Education

Bachelor’s Degree or relevant experience

Tools

Prisym labeling system

Adobe Illustrator

Enterprise CMS systems

Job description

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 labels 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.
• 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, 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 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.

Ireland Pay Ranges:

• Ireland: €49,000 - €82,000 EUR Annual

At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.