Global Labeling Compliance Strategist

Cardinal Health; Illinois; On-site; USD 105,000 - 150,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

Payday advances / myFlexPay access

Flexible spending accounts (FSAs)

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health seeks a Regulatory Affairs Manager to lead Global Labeling Compliance for medical devices. This role ensures labeling, packaging and IFU content meet global regulatory requirements and environmental directives across markets.

You will manage the labeling lifecycle from strategy to artwork approval, coordinating with R&D, Packaging, and Marketing to deliver compliant, user-friendly labeling across regions.

Qualifications

• 7-10 years of experience in Regulatory Affairs within the medical device industry.
• Experience in global medical device labeling, including labeling content, IFUs, and artwork in a regulated environment.
• Experience interpreting environmental regulations (REACH, RoHS, WEEE, PPWR) for labeling requirements.

Responsibilities

• Develop, implement, and maintain a harmonized global labeling strategy.
• Own end-to-end labeling lifecycle including content development, review, approval, and maintenance in a QMS.
• Monitor global regulatory changes (FDA, EU MDCG) and assess impact on labeling.
• Ensure labeling complies with FDA 21 CFR 801, EU MDR/IVDR GSPRs, and other standards.
• Lead UDI implementation across labels and packaging.
• Oversee symbols and content on labeling (ISO 15223-1, ISO 7000).
• Manage country-specific labeling requirements including translations and local marks.

Skills

Global labeling

Regulatory strategy

Cross-functional leadership

Regulatory intelligence

Risk management (ISO 14971)

Attention to detail

Project management

Education

Bachelor’s degree in scientific, engineering, life sciences, or related field

Regulatory Affairs Certification (RAC) a plus

Job description

Cardinal Health seeks a Regulatory Affairs Manager to lead Global Labeling Compliance for medical devices. This role ensures labeling, packaging and IFU content meet global regulatory requirements and environmental directives across markets.

You will manage the labeling lifecycle from strategy to artwork approval, coordinating with R&D, Packaging, and Marketing to deliver compliant, user-friendly labeling across regions.