About the role
Responsibilities:
- Serve as the Global Labeling core team member for company labeling 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 eLabeling for all labeling documents, such as but not limited to IFU, surgical technique, and creating material specifications and formats for printed IFU.
- Lead CAPAs, NCR, and complaint investigations and implement corrective and preventative action.
- 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 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.
Requirements:
- Bachelor's degree in a science or technical field with 0+ years' experience in a labeling or relevant capacity.
- Associate degree in science or a technical field with 2+ years' experience in a labeling or relevant capacity.
- High school diploma or equivalent 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.