Labelling Designer
Responsibilities:
- 5 years minimum experience in Content Labeling, of which 3 years should be in the medical device industry
- Should have worked in EU MDR related label design changes
- Experience in labeling software (NiceLabel, Codesoft, Bartender, Prisym, Loftware, Esko, Seagull) at least in one
- Experience with PLM applications like Windchill, Teamcenter, SAP
- Collaborate with product SMEs to assess and determine label requirements and content: Regulatory Affairs, Product Development, Product Safety Engineers, 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
- Create labeling source files for signature review and approval
- Use specialized labeling software to generate label templates and enter label data, text, and graphics into a database for a 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
- Support multiple simultaneous labeling projects for new products, mergers and acquisitions, and label maintenance
- Perform troubleshooting of electronic files as needed
- Review labels for completeness and presentation
- 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 the language-translation process such as requirements, costs, and timelines
- Communicate the 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, correct and compliant with FDA, EU and any other applicable requirements
- Proficiency in Adobe product platforms (Acrobat, Illustrator, InDesign, Photoshop)