Global Labeling & Regulatory Strategy Lead

Cardinal Health; Dublin (OH); On-site; USD 105,000 - 150,000; Full time

Benefits offered by this job

Medical coverage

Health savings account (HSA)

401k savings plan

Paid time off

Dental coverage

Vision coverage

Job summary

Cardinal Health is seeking an experienced Regulatory Affairs Manager to lead Global Labeling Compliance, overseeing labeling for products, packaging, and IFUs. You will translate complex regulatory requirements from the FDA, EU MDR, and environmental directives into clear labeling content and artwork, ensuring worldwide compliance.

You will own end-to-end labeling lifecycle, drive strategy, monitor regulatory changes, and collaborate with R&D, Marketing, and packaging teams to mitigate risk and

Qualifications

• Bachelor’s degree in scientific, engineering, life sciences, or related field is preferred or equivalent work experience.
• An advanced degree or Regulatory Affairs Certification (RAC) is a plus.
• 7-10 years of experience in Regulatory Affairs within the medical device industry.
• Experience interpreting environmental regulations (REACH, RoHS, WEEE, PPWR) for labeling.
• Global expertise across the US, EU, Canada, Japan, and Australia preferred.
• Exceptional attention to detail with strategic leadership capabilities.

Responsibilities

• Develop, implement, and maintain a harmonized global labeling strategy.
• Own the entire labeling lifecycle including content, approval, and artwork in QMS.
• Monitor global labeling regulatory changes and assess impact on labeling.
• Ensure compliance with FDA 21 CFR 801, EU MDR/IVDR, and other standards.
• Lead UDI implementation on labels and packaging across markets.
• Oversee symbols, language translations, and country-specific labeling requirements.
• Manage environmental and sustainability labeling per WEEE, REACH, RoHS, PPWR.
• Collaborate with R&D, Packaging, Supply Chain, Marketing, and design teams.
• Integrate labeling controls into design controls, change control, and risk management.

Skills

Regulatory affairs

Global labeling

Leadership

Project management

Regulatory intelligence

Strategic thinking

Communication

Risk management

Education

Bachelor’s degree in scientific/engineering or related field

Regulatory Affairs Certification (RAC)

Job description

Cardinal Health is seeking an experienced Regulatory Affairs Manager to lead Global Labeling Compliance, overseeing labeling for products, packaging, and IFUs. You will translate complex regulatory requirements from the FDA, EU MDR, and environmental directives into clear labeling content and artwork, ensuring worldwide compliance.

You will own end-to-end labeling lifecycle, drive strategy, monitor regulatory changes, and collaborate with R&D, Marketing, and packaging teams to mitigate risk and