Global Labeling Compliance Lead – Medical Devices

Cardinal Health; Mansfield (MA); On-site; USD 105,000 - 150,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k savings plan

Health savings account (HSA)

Paid time off

Job summary

Cardinal Health seeks a Regulatory Affairs Manager to own Global Labeling Compliance, overseeing labeling for on-device labels, packaging, and IFUs. You will translate complex FDA, EU MDR, and environmental rules into compliant labeling strategy and execution.

You will guide cross‑functional teams in R&D, packaging, and marketing, ensuring consistency, risk mitigation, and QMS integration across markets worldwide.

Qualifications

• 7-10 years of Regulatory Affairs experience in the medical device industry, preferably with labeling focus.
• Experience creating and managing labeling content, IFUs, and artwork in a regulated environment.
• Experience interpreting environmental regulations (REACH, RoHS, WEEE, PPWR) for labeling.
• Global labeling expertise across US, EU, Canada, Japan, and Australia preferred.
• ISO 14971 risk management applied to labeling processes and changes.
• Strong leadership, strategic thinking, and proactive regulatory vigilance.

Responsibilities

• Develop, implement, and maintain a harmonized global labeling strategy across product lines and markets.
• Own end-to-end labeling lifecycle including content development, review, approval, and artwork in a controlled QMS.
• Monitor regulatory landscape for labeling changes and assess impact on product labeling.
• Ensure compliance with FDA 21 CFR 801, EU MDR/IVDR GSPRs and other global standards.
• Lead UDI implementation on label and packaging levels.
• Collaborate with R&D, Packaging, Supply Chain, Marketing, and Design teams.
• Apply environmental labeling requirements (WEEE, RoHS, REACH, PPWR) and symbols correctly.
• Drive cross-functional processes to embed labeling controls in design, change control, and risk management.

Skills

Regulatory affairs

Global labeling

Project management

Leadership & influence

Risk management (ISO 14971)

Regulatory intelligence

Communication

Attention to detail

Strategic thinking

Cross-functional collaboration

Education

Bachelor’s degree in science/engineering

Regulatory Affairs Certification (RAC)

Advanced degree

Job description

Cardinal Health seeks a Regulatory Affairs Manager to own Global Labeling Compliance, overseeing labeling for on-device labels, packaging, and IFUs. You will translate complex FDA, EU MDR, and environmental rules into compliant labeling strategy and execution.

You will guide cross‑functional teams in R&D, packaging, and marketing, ensuring consistency, risk mitigation, and QMS integration across markets worldwide.