Labeling Specialist
Zimmer Biomet

Valued Team member: We are glad you are exploring new opportunities within Zimmer Biomet!

What You Can Expect

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 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.

How You'll Create Impact

• 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.
• 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.
• 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.
• 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.

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

What Makes You Stand Out

• 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.

Your Background

• 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.
• Regulatory Affairs, Development, or Quality knowledge or experience preferred.

Travel Expectations

• Up to 5%

EOE/M/F/Vet/Disability

This job has expired.