15h Left Staff Label Designer

4 weeks ago

Cork, Cork, Ireland Stryker Ireland Full time

**18 months fixed term contract** SUMMARY The Staff Label designer will be primarily responsible for supporting the R&D Business Units, Product Engineering and Regulatory Affairs to meet labelling requirements for global product compliance and distribution This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently and drive assignments for themselves and their function. Develops and maintains labels for complex medical devices. Collaborates with product subject matter experts to gather and assess labeling content providing best practices and standardization across our global business. 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. KEY AREAS OF RESPONSIBILITY Own and drive the best practices for label design across our division globally. Fully understand and be able to apply global labeling standards and regulations. Additionally, be able to coach and mentor others on the team in this area of expertise. 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. Use specialized labeling software to generate templates and enter label data, text, and graphics into label database for print-on-demand label system. Supports multiple business units across the division. Ensure barcodes pass verification testing. Use desktop publishing software to design labels produced by external suppliers. Design label formats for functional usability by healthcare staff according to requirements based on global markets. Support multiple concurrent, complex labeling projects for new products, mergers and acquisitions, and label maintenance Collaborates globally with Technical Publications functions to discover best practices, collaborate on how we can address an issue, gap or strategy. Reaches out often and contributes to process improvements that impact Technical Publications to more efficiently impact the organization to establish a baseline across Stryker. Successful release of complex instructional project (software, multiple divisions, product interdependence, multiple market requirements). Participate in new product label planning meetings and capture requirements using quality system planning documents. Select appropriate label materials for labels applied to packages and products in collaboration with packaging engineers. Drive and lead innovation and strategic initiative projects. May be the Division Process Owner for labeling. Solve complex problems by filtering, prioritizing, analyzing and validating complex and dynamic material. As needed, support label translation strategies that satisfy international labeling needs. As needed, own and drive any applicable NC/CAPAs to closure. 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. 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. QUALIFICATIONS KNOWLEDGE SKILLS Level 8 Bachelors Degree in an Communications, Data Management, Procurement, General Business Management, Regulatory Sciences, or equivalent is required. 4+ years' experience with software and/or medical devices Excellent verbal, writing, and interpersonal communication skills Excellent communication, time management, and organization skills with high emphasis on attention to detail. Experience independently researching products by reading technical and other documentation, interviewing subject matter experts, and use of prototype hardware and software Product knowledge and proven ability to organize, write and develop instructional materials through development of text applications of graphical elements, illustrations, charts, diagrams, etc. Experience developing deliverables for language translation to a global audience Experience with application of domestic and international regulatory requirements; and standards and guidance pertaining to medical device labeling requirements, i.e., Code of Federal Regulations governing medical device labeling (e.g. FDA, EU MDR) Experience working with engineering and regulatory teams Hands-on experience with database compilation labeling systems such as i.e., Prisym preferred. Experience with Adobe Illustrator and enterprise CMS system desirable. Strong working knowledge of Microsoft Office, Teams, etc. Experience working with component content management systems as related to the modular reuse of content Ability to work independently and motivated to perform at a high-level without constant supervision #IJ To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.

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