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The Labeling Sr Specialist is a Subject Matter Expert (SME) responsible for managing device labeling (including, but not limited to labels, IFUs, UDI, and labeling systems) as necessary to market client devices.
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 in a timely manner.
Solid functional understanding of other departments' needs, capabilities, and system interfaces.
Act as an adviser and mentor to department members and project teams.
Strong ability to balance needs of all departments to meet customer expectations and project schedules.
Assist in establishing and meeting budget commitments.
Principal Duties and Responsibilities
Serves as the Global Labeling SME for client labeling initiatives by working with Regulatory, Development, and other department team members to develop and maintain labeling content that complies with labeling regulations (US, EU, 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.
Serves as a mentor for Global labeling personnel and project team members, providing labeling support, training, and problem-solving assistance.
Ensures compliant labeling creation, approval, maintenance, and label release, including appropriate procedures, work instructions, and forms.
Expected Areas of Competence
Ability to build relationships with other departments (i.e. Marketing, Packaging, Development)
Understands the overall business environment, the orthapaedic industry, and the marketplace
Understanding of Zimmer Biomet products and their intended use
Willingness to learn and stay abreast of labeling regulations for medical devices
Strong written and oral communication, teamwork, and organizational skills
Education/Experience Requirements
B.S. in a technical discipline plus a minimum of 5 years of experience required in a labeling capacity, OR an equivalent combination of education and labeling experience.
Significant experience and expertise with Innovatum's ROBAR Enterprise Label Management System in a regulated environment is highly preferred
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