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Labeling Specialist
hace 3 meses
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 talent 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 included, respected, empowered, and recognized.
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 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.
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. 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.What Makes You Stand Out
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.Your Background
English proficiency is required (C1) Bachelor's degree in science or technical area; 3+ years of experience in a Labeling capacityPlease note that you must submit your resume in English at the time of applying, or your application will not be considered.
Travel Expectations
EOE/M/F/Vet/Disability
