Labeling Specialist, Graphic Designer - San Diego Job at Werfen North America in

The Quality Labeling Graphic Designer oversees the creation and revision of product labeling, adhering to corporate and branding guidelines, to support existing and new products both domestically and internationally. The Quality Labeling Graphic Designer ensures compliance to FDA and ISO standards, IVDR and MDR regulations, IVDD and MDD directives and other regulations as they pertain to labeling / labels.

Responsibilities

• Oversee the labeling process for new and existing IVD and MD products.
• Interface with Marketing, Regulatory Affairs, Supply Chain Management, Engineering, Clinical, and Manufacturing in the labeling development and revision process to ensure the requested deliverables are correct and meet specifications.
• Develop and maintain the design and layout of product manuals, IFUs, packaging and labels.
• Incorporate redlined changes made to artwork drafts to create final drafts and source files.
• Clarify open questions and request missing information on redlined artwork.
• Assist labeling creators / reviewers based on a strong understanding of regulatory standards and guidelines for IVD and MD labeling / labels.
• Proofread and act as departmental quality control for product descriptions and labeling content.
• Create and revise BarTender barcode label PDF artwork and source files.
• Obtain the required labeling requirement approvals.
• Provide documentation for labeling change orders : PDF artwork redlines, PDF artwork final drafts, source files, summary of changes, and certificates of translation.
• Manage translation supplier projects, priorities, budget, and delivery timelines.
• Coordinate with outside suppliers as needed to facilitate the ordering, receipt, and implementation of new and revised labeling.
• Other duties as assigned, according to the changing needs of the business.

Qualifications

Competencies

Werfen is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, or any other protected characteristic.

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