Sr. Specialist (Labeling)

The Senior Specialist is responsible for managing device labeling (including, but not limited to, labels, IFUs, translations, UDI, and labeling systems) as necessary to market Zimmer Biomet products. Advanced understanding and demonstrated leadership of label development, IFU development, change management systems, and global labeling regulations, requirements, procedures, and concepts. Demonstrate strong problem-solving skills; analyze all aspects of a situation, challenge current methods, identify potential solutions, and implement the best solution promptly. Solid functional understanding of other departments' needs, capabilities, and system interfaces. Act as an advisor and mentor to department members and project teams. Strong ability to balance the needs of all departments to meet customer expectations and project schedules. Assist in establishing and meeting budget commitments.

Responsibilities:

• Serves as the Global Labeling SME for Zimmer Biomet labeling initiatives by working with regulatory, development, and other department team members to develop and maintain labeling content and processes that comply with labeling regulations (US, EU, and OUS as required).
• Leads and manages projects for both company and departmental labeling needs to ensure execution of high-quality, efficient labeling, including acquisitions, development, regulatory, UDI, packaging, distribution, external alliance partners, and trademark labeling initiatives.
• Lead CAPAs, NCRs, and complaint investigations and implement corrective and preventive actions.
• Serve as a mentor for global labeling personnel and project team members, providing labeling support, training, and problem-solving assistance.
• Update global and site-level procedures and support other QMS-related activities, including standards assessments.

Requirements:

• Bachelor's degree in a science or technical field with 4+ years' experience in a labeling or relevant capacity.
• Associate degree in a science or technical field with 6+ years' experience in a labeling or relevant capacity.
• High school diploma or equivalent required with 8+ years of experience in a labeling or relevant capacity.
• Lead CAPAs, NCR, and complaint investigations and implement corrective and preventive actions.
• Experience in labeling, supporting creation, review, and maintenance of product Labeling across the lifecycle.
• Regulatory requirements and standards applicable to labeling (e. g., FDA, EU MDR/IVDR, UDI, and market-specific regulations), ISO 15223 ISO 20417
• US and EU Labeling.
• Clear and confident communication skills to discuss labeling decisions, clarify requirements, and provide inputs during cross-clarifying reviews

What Makes You Stand Out:

• Demonstration of strong problem-solving skills; able to analyze all aspects of a situation, identify potential solutions, and implement the best solution promptly.
• Strong ability to build and strengthen relationships with other areas of the organization (i. e., marketing, packaging, development, and IT) and other business sites.
• Good understanding of how labeling systems communicate with other business systems.
• Ability to create a project plan and drive projects.
• Exceptional attention to detail, organization, and multitasking skills.
• Commitment to learn and stay abreast of medical device regulations.
• Understand the overall business environment, the orthopedic industry, and the marketplace.