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Regulatory Affairs Manager - Labeling at Cardinal Health - ApplyBlast

Regulatory Affairs Manager - Labeling

Cardinal Health

3 months ago

Remote

Full Time

Senior

11 applicants

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About this role

A Strategic Regulatory Affairs Manager leads the end-to-end alignment of medical device labeling, packaging, and digital assets with evolving international regulations. This role oversees global compliance for environmental sustainability mandates and serves as the central subject matter expert for all product labeling and Instructions for Use. The position requires deep expertise in translating complex regulatory frameworks from authorities like the FDA and EU MDR into clear, compliant labeling strategies.

Responsibilities

Develop and maintain a harmonized global labeling strategy for all product lines
Manage the end-to-end labeling lifecycle from content development to final artwork approval
Interpret global regulatory requirements from FDA, EU MDCG, and environmental directives
Oversee Unique Device Identification (UDI) implementation across all global markets
Serve as the critical link between regulatory strategy and market-facing materials

Skills

Qualifications

Bachelor's degree in Life Sciences or EngineeringRegulatory Affairs Certification (RAC)7-10 years of experience in Regulatory Affairs within the medical device industry

About Cardinal Health

cardinalhealth.com

Headquarters

Dublin, Ohio, United States

Company Size

10001+ employees

Founded

1971

View Profile

Cardinal Health is a global healthcare services and products company dedicated to enhancing the cost-effectiveness of healthcare. The company provides essential logistics, medical supplies, and solutions that focus on improving patient care while reducing costs and enhancing operational efficiency. Committed to quality and innovation, Cardinal Health plays a pivotal role in the healthcare supply chain, ensuring that the right products are delivered to meet the needs of healthcare providers and patients alike.