Hiring: Regulatory Affairs Manager - Labeling Company: Cardinal Health Location: Waukegan, IL Job Posted Time: 2026-09-10 11:24:31 Target Skills & Keywords : Project Management, R, Regulatory Compliance, Risk Management About the job Experience: •7-10 years of experience in a Regulatory Affairs role within the medical device industry, preferred •Specific and demonstrated experience in global medical device labeling, including the creation and management of labeling content, IFUs, and artwork in a regulated environment, preferred. •Global Expertise: In-depth knowledge of labeling requirements for major global markets, including the US, EU, Canada, Japan, and Australia, preferred. •Exceptional Attention to Detail: A meticulous and precise approach to reviewing and managing complex information is absolutely essential for this role. •Strategic & Proactive Thinking: Ability to anticipate regulatory trends in labeling and develop proactive, long-term strategies to ensure compliance and mitigate risk. Required Skills: •This role is focused on the strategic and operational execution of global labeling compliance, requiring exceptional attention to detail and cross-functional leadership. •Global Labeling Strategy & Lifecycle Management •Global Labeling Strategy: Develop, implement, and maintain a harmonized global labeling strategy that ensures consistency and compliance across all product lines and markets. •End-to-End Process Ownership: Manage the entire labeling lifecycle, including the creation, review, approval, and maintenance of all labeling content and artwork within a controlled Quality Management System. •Regulatory Intelligence for Labeling: Proactively monitor the global regulatory landscape for any new or revised labeling requirements. Interpret and assess the impact of changes from sources like the FDA, EU MDCG, and other competent authorities on product labeling. •Core Regulatory Compliance: Ensure all product labeling strictly adheres to global medical device regulations, including FDA 21 CFR 801, EU MDR/IVDR General Safety and Performance Requirements (GSPRs Chapter III), and other key international standards. •UDI and Device Identification: Lead and manage the implementation and maintenance of Unique Device Identification (UDI) requirements on all applicable label and packaging levels across global markets. •Symbols and Content: Oversee the correct and consistent use of harmonized symbols (e.g., ISO 15223-1, ISO 7000), safety warnings, contraindications, and other required content on all labeling. Compensation: •$105,100 - $150,100 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!