Product Label Specialist

1 day ago

Cork, Cork, Ireland beBeeLabelDesigner Full time €60,000 - €80,000
Senior Label Designer Job Description

We are seeking a Senior Label Designer to join our team. The ideal candidate will have experience in label design and development, as well as strong organizational and time management skills.

This role involves developing and maintaining product labels to meet labelling requirements for medical devices. You will collaborate with product subject matter experts to gather and assess labelling content, execute label format, and compile content using specialized software.

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

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

Key Responsibilities:

  • 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 specialized 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

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