Manager/Sr. Manager, Labeling Compliance

Role: Manage and oversee product labeling activities to ensure compliance and quality for medical devices or pharmaceuticals. Responsibilities: develop, control, and approve labeling content, including IFUs, manuals, labels, and artwork; lead labeling change processes, including ECO/DCC activities and Labeling Committee reviews; coordinate with external vendors for translations, printing, and labeling; monitor global regulatory labeling requirements; drive process improvements. Requirements: 5+ years (Manager) or 8+ years (Senior Manager) in medical device/pharmaceutical industry; experience with regulated product labeling, document control, and global standards; strong technical writing and communication skills; proficiency in Microsoft Office and Adobe Acrobat; ability to manage multiple projects and collaborate cross-functionally with Regulatory, Quality, R&D, Clinical, and Commercial teams; working knowledge of QMSR preferred. HighValue: experience in regulated labeling for medical devices or pharmaceuticals, global regulatory compliance, process improvement, and cross-functional collaboration. WorkSetup: onsite in Aliso Viejo, CA; salary range $107,000 - $179,200; role level based on experience and leadership capabilities.