Global Labeling & Compliance Leader (Remote)

Hobbsnews; Mansfield, Northern (MA, KY); Hybrid; USD 105,000 - 150,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) plan

Paid time off

Job summary

Cardinal Health in the United States seeks a Regulatory Affairs Manager for Global Labeling Compliance to lead labeling strategy across devices, packaging, and IFU, ensuring alignment with FDA, EU MDR, and environmental directives.

You will own end-to-end labeling lifecycle, manage content, artwork, translations, and country-specific requirements while coordinating with R&D, QA, Marketing, and suppliers to mitigate risk and enable worldwide market access.

Qualifications

• Bachelor’s degree in scientific, engineering, life sciences, or related field; RAC is a plus.
• 7–10 years in Regulatory Affairs in medical devices, with labeling experience.
• Experience applying environmental regulations (REACH, RoHS, WEEE, PPWR) to labeling.

Responsibilities

• Develop, implement, and maintain a global labeling strategy across devices, packaging, and IFUs.
• Own end-to-end labeling lifecycle including content, artwork, and translations within a QMS.
• Monitor regulatory labeling changes (FDA, EU MDCG) and interpret impacts on labeling.

Skills

Regulatory knowledge

Project management

Attention to detail

Leadership

Communication

Education

Bachelor’s degree in science/engineering

Job description

Cardinal Health in the United States seeks a Regulatory Affairs Manager for Global Labeling Compliance to lead labeling strategy across devices, packaging, and IFU, ensuring alignment with FDA, EU MDR, and environmental directives.

You will own end-to-end labeling lifecycle, manage content, artwork, translations, and country-specific requirements while coordinating with R&D, QA, Marketing, and suppliers to mitigate risk and enable worldwide market access.