Aliso Viejo, California, USA
14 days ago
Sr Labeling Lead
Lead project teams in developing, finalizing, and implementing product labels, instructions for use, and patient implant cards. Ensure labels adhere to regional requirements and international standards along with cross-functional input from Marketing, R&D, Regulatory Affairs, and Legal. Job duties:Responsible for end-to-end labeling activities for multiple projects from initiation to product launch. Lead cross-functional project teams to develop labels that meet the needs of customers and all regional regulatory requirements. Plan and execute label development schedule, ensuring timely delivery of draft labels for submissions and release of finished labels into production. Ensure all labeling changes comply with company policies and procedures. Collaborate and provide guidance to Labeling Design team to ensure labeling requests are completed accurately and promptly. Update project tracker and proactively communicate any delays or scope changes to proper stakeholders. Ensure appropriate testing is performed prior to implementation of pre-production printing (e.g., legibility, bar code scanning, content accuracy, language, etc.). Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization. Perform additional duties as assigned.
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