Labeling Specialist Jobs

* Please note, this position is a hybrid role, that sits partially onsite, in Warsaw, Indiana.

Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.

This position is responsible for leading medical device labeling projects (including, but not limited to product labels, IFUs, translations, labeling systems, and UDI initiatives) as necessary to market Zimmer Biomet products. It requires demonstrated leadership and communication skills, as well as a broad understanding of the label and IFU development process, change management systems/procedures/concepts, and labeling systems. This position requires strong knowledge on U.S., EU, OUS, and UDI labeling regulations/requirements and an ability to stay abreast on those regulations/ requirements. Shows ability to generate labeling solutions as new labeling requirements unfold. Works effectively, efficiently and productively with all Zimmer Biomet departments and team members. Strong attention to detail, written and oral communication, teamwork, and organizational skills are essential, as well as an understanding of Zimmer Biomet products and their use.

• Serve as a mentor for Global Labeling representatives, providing regulation knowledge, support and training; as well as company-wide labeling SME working with Regulatory Affairs, Development, Brand, Packaging Development, Manufacturing, and IT) and other Zimmer Biomet sites to maintain compliant labeling needs.
• Work with Regulatory, Development, Brand, Packaging Development, and other departments to develop/create labeling that complies with US, EU, OUS, and UDI labeling regulations and requirements, as required.
• Serve as the Global Labeling core team member for Zimmer Biomet labeling initiatives, including but not limited to NPI (New Product Introduction), maintenance projects, PMI/custom products, and UDI tasks.
• Initiate change requests for new and revised labeling, work with Labeling Coordinators to create, maintain, and implement compliant labeling.
• Review product labeling against indicated content to ensure compliance with labeling regulations and requirements (U.S., EU, OUS, and USI as required), and approve change request to release labeling documentation for Production/Manufacturing label usage.
• Coordinate services and works effectively with vendors and suppliers of services (e.g., translation vendors, instrument and/or implant suppliers) to ensure execution of high quality deliverables.

• Broad knowledge and understanding of U.S., EU, OUS, and UDI labeling regulations, as well as overall FDA and MDD/MDR regulations preferred. Ability to stay abreast of medical device regulations.

• Demonstration of strong problem solving skills. Able to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely manner.

• Strong ability to build and strengthen relationships with other areas of the organization (i.e. Regulatory Affairs, Brand, Development, Packaging Development, IT, etc.) and other Zimmer Biomet sites.

• Good understanding of how labeling systems communicate with other business systems

• Ability to lead team efforts on labeling projects.

• Able to perform work with a high degree of accuracy and minimal supervision.

• Exceptional written and oral communication. Strong attention to detail. Ability to multi-task, handle numerous project at a given time, and remain organized

• Commitment to learn and stay abreast of medical devices regulations. Understand the overall business environment, the orthopedic industry, and the marketplace.

Bachelor’s degree in science or technical area; 3+ years of experience in a Labeling capacity; or an equivalent combination of education and experience is required.

Up to 5%

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.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. This is why we offer you a competitive rewards package that includes medical, dental, vision, life and disability insurance, wellness incentives, employee assistance programs as well as paid time off for vacation and holidays.

EOE/M/W/Vet/Disability