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 labels includes hospital and healthcare staff in global markets. Labels must comply with medical device regulations, standards, and business requirements. Essential

Duties

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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

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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. #IJ 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. If you’d like to learn more about the salary or the benefits associated with this role, your recruiter will be happy to walk you through the details as you progress through the hiring process. Travel Percentage: 10% Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.