Job Title: Labeling Specialist

Job Description

Under minimal supervision, the Labeling Specialist develops and maintains labels for medical devices. This role involves collaborating with product subject matter experts to gather and assess labeling content, executing label format, and compiling content using specialized software. The audience for these labels includes hospital and healthcare staff in global markets. The Labeling Specialist must comply with medical device regulations, standards, and business requirements.

Responsibilities

• Collaborate with product subject matter experts, including Regulatory Affairs, Product Development, Product Safety Engineering, Packaging Engineers, Clinical Sciences, Marketing, Trade Compliance, etc., to assess and determine label requirements and content.
• 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.
• Support label translation strategies that satisfy international labeling needs as needed.
• Support multiple concurrent labeling projects for new products 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.
• 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.

Essential Skills

• Proficiency in labeling for medical devices.
• Understanding of EUMDR and FDA regulations.
• 5+ years of labeling experience.

Work Environment

The role involves working with specialized labeling software and desktop publishing tools. The Labeling Specialist will collaborate with various departments and external suppliers, handling multiple projects simultaneously. The position requires attention to regulatory compliance and may involve international communication for label translation strategies.