Manager, Quality Global Labeling

Job Summary

Leading end-to-end improvements in global labeling processes, the full-time remote Manager, Quality Global Labeling will ensure compliance and operational excellence across distribution centers and third-party logistics partners while guiding a team in support of regional supply chain labeling systems and Instructions for Use (IFUs).

Key responsibilities

• Establishes and oversees global labeling processes in collaboration with Regulatory Affairs and Supply Chain to ensure compliance for medical device products
• Supports troubleshooting and problem-solving for deliver sites, facilitating investigations and connections with key stakeholders
• Maintains communication with regions to share process improvements and ensure compliance with emerging regulations

Required qualifications

• Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or a related field; advanced degree preferred
• 6+ years of experience in Quality, Regulatory Affairs, or Compliance within a medical device or regulated healthcare environment
• Strong knowledge of global medical device labeling regulations and standards (e.g., FDA, EU MDR, ISO 13485)
• Experience with Microsoft Power Apps and process improvement methodologies (Lean, Six Sigma)
• Demonstrated ability to work in a highly matrixed, cross-functional environment