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THE ROLEThe incumbent is responsible for creation of new design label (artwork, drawing & specification) and changes as required by customers and regulatory requirements. Ensure all design labels are controlled.- JOB RESPONSIBILITIES:
- Work with the graphics and translation to create artwork, drawings, and associated documentation for labeling.
- Ensure that labeling artwork and proofs are accurate and meet all medical device regulatory and customer requirements.
- Ensure regulatory compliance, accuracy, timely completion and version control of all new and revised labeling.
- Develop/update product structure and documents to ensure labeling is correctly implemented into the product.
- Perform continuous coordination, monitoring and expediting of labeling changes to meet established deadlines for regulatory submission and production, as well as product launches.
- Be familiar with the labeling requirements from various countries in order to provide guidance and information for labeling as needed.
- Work with initiator or project team (operation, marketing, regulatory affairs, quality, R&D) to identify potential labeling issues and to define and implement solutions.
- Work with procurement and labeling print vendors to ensure correct labeling components are produced.
- Manage barcode processes and systems as related to product labeling.
- Working knowledge of computer-generated labeling systems
**REQUIREMENTS**:
- Min Diploma
- Experience in label design and printing and have understanding of pantone color coordination.
- Proficiency in Microsoft Word, Excel, Adobe Illustrator, Adobe Photoshop or equivalent
- Experience in QA/RA
- Handle Label Issue
