Global Labeling Specialist

As a 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.

Responsibilities:

• Serve as the Global Labeling core team member forlabeling initiatives, including but not limited to NPD (new product development), CPI (core product improvement), and UDI tasks.
• Work with Regulatory, Development, Brand, Packaging Development, Manufacturing, and Other departments to develop/create labeling that complies with US, EU, and UDI labeling regulations and requirements, as required.
• Ensures compliant labeling creation, accurate data loaded to labeling systems, approval, maintenance, and label release, including appropriate procedures, work instructions, and forms.
• Coordinate services and work effectively with vendors and suppliers of services (e. g., translation vendors, print vendors, and instrument and/or implant suppliers) to ensure execution of high-quality deliverables.
• Complete destination labeling and e-labeling for all labeling documents, such as, but not limited to, IFU, surgical technique, creating material specifications, and formats for printed IFU.
• Lead CAPAs, NCR, and complaint investigations and implement corrective and preventative action.

Requirements:

• Broad knowledge and understanding of US, EU, and UDI labeling regulations, as well as overall FDA and MDD/MDR regulations, is preferred.
• Demonstration of strong problem-solving skills; able to analyze all aspects of a situation, identify potential solutions, and implement the best solution promptly.
• Strong ability to build and strengthen relationships with other areas of the organization (i. e., marketing, packaging, development, and IT) and other business sites.
• Good understanding of how labeling systems communicate with other business systems.
• Exceptional attention to detail, organization, and multitasking skills.
• Understand the overall business environment, the orthopedic industry, and the marketplace.
• Bachelor's degree in a science or technical field with 0+ years' experience in a labeling or relevant capacity.
• Associate degree in a science or technical field with 2+ years' experience in a labeling or relevant capacity.
• A high school diploma or equivalent is required with 4+ years of experience in a labeling or relevant capacity.
• Hands-on experience with Adobe InDesign and familiarity with Adobe Creative Suite tools.
• Strong learning agility, the ability to quickly learn, relearn, and adapt to new tools, processes, and regulatory requirements.
• Excellent verbal and written communication skills for effective coordination with cross-functional teams.
• High attention to detail and ability to follow structured processes and documentation standards.
• Smart, proactive mindset with the ability to ask the right questions and take ownership of assigned tasks.