Labeling Specialist (679697) at Zimmer US in Westminster, Colorado

Job Description:

Job Summary

Zimmer Biomet is a world leader in musculoskeletal health solutions. 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 office 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 label and IFU development, change management systems/procedures/concepts, and labeling systems. This position must have the ability to work effectively and efficiently with all Zimmer Biomet team members, have a good understanding of global labeling regulations and requirements, and have the ability to generate creative labeling solutions as new labeling requirements unfold. 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.

Principal Duties and Responsibilities

• Serve as the Global Labeling core team member for Zimmer Biomet labeling initiatives, including but not limited to NPD (new product development), maintenance projects, PMI/custom products, and UDI tasks.


• Work with Regulatory, Development, Brand, Packaging Development, and Other departments to develop/create labeling that complies with US, EU, and UDI labeling regulations and requirements, as required.


• 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, and approve/release labeling documentation for Production/Manufacturing label system usage.


• Coordinate services and works effectively with vendors and suppliers of services (e.g., translation vendors, print vendors, instrument and/or implant suppliers) to ensure execution of high quality deliverables.


• Serve as a mentor for Global Labeling colleagues, providing regulation knowledge, support and training; as well as company-wide labeling SME working with Manufacturing, Development, IT and other Sites to maintain compliant labeling needs.

Expected Areas of Competence

• Broad knowledge and understanding of US, EU, and UDI labeling regulations, as well as overall FDA and MDD/MDR regulations preferred.


• 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. Marketing, Packaging, Development, IT) and other Business Sites.


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


• Ability to lead team efforts on Labeling projects.


• Exceptional attention to detail, organization, and multi-tasking skills.


• Commitment to learn and stay abreast of medical devices regulations.


• Understand the overall business environment, the orthopedic industry, and the marketplace.

Education/Experience Requirements

• 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.

Travel Requirements

 Up to 5%

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.

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.

Compensation Range 51,400-66,150