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Stryker Label Designer Technical Publications in Cork, Ireland

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

Summary

As a member of the Technical Publications team, create and revise product labels to meet labeling requirements for medical devices. Collaborates with product subject matter experts to gather and assess labeling content. Executes label format and compiles content using specialized software

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. The job requires attention to detail in making evaluative judgements based on the analysis of factual information

What you will do:

  • ​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, drive and 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

What you will need:

  • Bachelors Degree in an Communications, Data Management, Procurement, General Business Management, Regulatory Sciences, or equivalent is required.

  • Experience working with/entering data into data-driven software

  • Preferred experience navigating challenges related to language translation

  • Preferred experience working with Excel, XML, DITA, HTML, Arbortext Editor, and labeling software

  • Preferred experience in a regulated industry, experience in translation and localization projects and experience with an external service supplier

  • Understanding of impact of language translation to format design

  • Highly developed computer skills and able to quickly learn new software

About Stryker

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 130 million patients annually. More information is available at stryker.com. (http:)

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

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