Werfenlife SA. is hiring: Labeling Specialist, Graphic Designer - San Diego in S

Overview

Position Summary: 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

• TECHNICAL QUALIFICATIONS: Strong hands-on experience and ability to develop and evaluate product manuals, instructions for use and other labeling / labels to ensure that the information is complete and correct.
• Proficiency with Adobe Creative Suite - Photoshop, Illustrator and InDesign.
• Experience with BarTender or other barcode label programs is preferred.
• Strong understanding of IVD and MD labeling / label standards, regulations, directives and guidances.
• Basic understanding of change control requirements; Computer literacy; good working knowledge of Microsoft Office programs.
• Strong planning, organizational and time management skills; Ability to prioritize urgent matters.

Competencies

• Attention to Detail
• Accuracy
• Outstanding Performance Standards
• Communication
• Discretion
• Multi-Tasking
• Collaboration
• Independence
• Professionalism
• Takes Initiative
• Problem Solving

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity / expression, national origin / ancestry, age, mental / physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.