Regulatory Affairs Manager – Labeling

Cardinal Health is hiring a Regulatory Affairs Manager - Labeling to lead global compliance initiatives at our Park, Lake County location. In this full-time position, you'll oversee the strategic alignment of medical device labeling, packaging, and digital assets across international markets while driving compliance with evolving global regulatory standards.

About the Role

As Regulatory Affairs Manager - Labeling, you'll own end-to-end compliance for medical device labels, packaging, and digital content against complex, multi-jurisdictional regulatory requirements. This role bridges traditional medical device labeling with emerging global mandates—including environmental sustainability requirements, materials of concern disclosure, and circular economy standards. You'll ensure Cardinal Health's medical devices meet rigorous international labeling standards while positioning the organization ahead of regulatory changes in the labeling and packaging landscape.

What You'll Do

• Lead the development and maintenance of medical device labeling strategies that align packaging and digital assets with international regulatory frameworks
• Monitor, interpret, and implement evolving labeling regulations across key jurisdictions and markets
• Direct the review, approval, and implementation of label updates for medical devices, packaging, and related digital platforms
• Coordinate cross-functional teams including quality, product development, and marketing to embed compliance requirements early in product lifecycles
• Develop and manage labeling content for digital channels with attention to accessibility and regulatory compliance
• Track and implement emerging requirements related to environmental sustainability, materials disclosure, and circular economy standards
• Maintain comprehensive documentation and audit trails demonstrating regulatory readiness and compliance posture

What We're Looking For

• Proven experience in regulatory affairs, medical device labeling compliance, or similar regulated industry roles
• Deep knowledge of FDA labeling regulations (21 CFR Part 801 and related sections) and international medical device requirements (EU MDR, ISO standards)
• Demonstrated track record managing complex compliance projects with multiple stakeholders
• Strong written and verbal communication abilities for translating regulatory requirements to cross-functional teams
• Keen attention to detail with excellent analytical and problem-solving skills
• Familiarity with environmental compliance, materials of concern labeling, and sustainability standards preferred

About Cardinal Health

Cardinal Health is a leading global healthcare services company that enables healthcare providers, pharmacies, and other care settings to deliver better outcomes. We partner with healthcare organizations to optimize supply chains, improve clinical workflows, and advance patient care.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.