Jacksonville, Florida, USA
30 days ago
Labeling Assoc Specialist

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. 

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards.  We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.


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 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. 

This is a hybrid position in Jacksonville, Florida. 

How You'll Create Impact 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.

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 Basic 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. Ability to build and strengthen relationships with other areas of the organization (i.e. Marketing, Packaging, Development, IT) and other Business Sites.Understanding of how labeling systems communicate with other business systemsExceptional attention to detail, organization, and multi-tasking skills.Commitment to learn and stay abreast of medical devices regulations.
 Your Background

Bachelor’s degree in science or technical area, or commensurate combination of education and experience within labeling. 

Travel Expectations

Up to 5%


EOE/M/F/Vet/Disability

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