Job Description

Job Summary

Zimmer Biomet Dental is a global leader in implant and restorative dentistry solutions with more than 60 years of industry experience. We are proud to be part of one of the largest musculoskeletal companies in the world. Our mission is to alleviate pain and improve the quality of life for people around the world. Every 10 seconds, 24 hours a day, and 7 days a week patients around the world receive a Zimmer Biomet product, resulting in helping millions of people each year. ZBDental

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 Zimmer Biomet 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 Zimmer Biomet 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

Travel Requirements

* Up to 10%

Additional Information

EOE/M/F/Vet/Disability

At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.