Regulatory Affairs Manager - Labeling

The Regulatory Affairs (RA) Manager of Global Labeling Compliance leads the end-to-end alignment of medical device labeling, packaging, and digital assets with evolving international regulations. This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements. Position Overview We are seeking a meticulous, strategic, and highly experienced Regulatory Affairs Manager to own and lead our Global Labeling Compliance program. This role is the central subject matter expert for all product labeling, including on-device labels, packaging, and Instructions for Use (IFU), ensuring full compliance with the complex and converging frameworks of global medical device and environmental regulations. You will be responsible for the entire labeling lifecycle, from content development and strategy to final artwork approval and implementation. This position requires a deep understanding of how to translate intricate regulatory requirements from diverse global authorities (e.g., FDA, EU MDR) and environmental directives (e.g., WEEE, PPWR, REACH) into clear, accurate, and compliant labeling. You will serve as the critical link between our regulatory strategy, product development, and market-facing materials, mitigating risk and ensuring our products can be sold worldwide. Key Responsibilities 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. Medical Device Labeling Compliance 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. Country-Specific Requirements: Manage all country-specific labeling requirements, including language translations, local health authority marks or logos, and specific formatting or content mandates. Environmental & Sustainability Labeling Compliance Environmental Labeling Expertise: Act as the primary expert for all environmental and sustainability labeling requirements driven by global directives. Symbol and Mark Management: Ensure the correct application of environmental symbols and marks, including those for the WEEE Directive, battery directives (e.g., crossed-out wheeled bin), recycling (e.g., \"Green Dot,\" Mobius loop), and packaging material identification. Substance-Driven Labeling: Manage all labeling requirements stemming from materials of concern (MOC) regulations. This includes ensuring necessary warnings or disclosures are present on labels or packaging as required by REACH, RoHS, California Proposition 65, and the EU MDR. Emerging Requirements: Stay ahead of and develop strategies for emerging environmental labeling trends, such as those related to the EU Packaging and Packaging Waste Regulation (PPWR), repairability scores, and the transition to electronic or digital labeling (eIFU). Cross-Functional Collaboration & Process Ownership Internal Collaboration: Serve as a central hub for collaboration on all labeling matters. Work with R&D, Packaging Engineering, and Supply Chain to ensure label content accurately reflects device specifications, material composition, and packaging configurations. Partner with Marketing to ensure brand consistency is maintained within the strict constraints of regulatory requirements. Collaborate with Graphic Designers to create, review, and approve compliant and user-friendly label artwork and IFUs. Process Integration: Integrate labeling controls seamlessly into the broader Quality Management System, including design controls, change control, risk management, and supplier management processes. Qualifications Education: 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. 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. Experience interpreting and applying environmental regulations (e.g., REACH, RoHS, WEEE, PPWR) to product labeling requirements is desired. 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. Project Management: Strong organizational and project management skills to manage multiple, concurrent labeling projects across different product lines and regions. Leadership & Influence: Proven ability to lead through influence, build consensus, and drive decisions across diverse, cross-functional teams. Risk Management: Ability to apply risk management principles (ISO 14971) to the labeling process, identifying and mitigating risks associated with labeling errors, such as product recalls, shipping holds, or regulatory enforcement actions. Communication: Excellent written and verbal communication skills, with the ability to clearly articulate complex labeling requirements to technical and non-technical audiences. What is expected of you and others at this level Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects. Participates in the development of policies and procedures to achieve specific goals. Recommends new practices, processes, metrics, or models. Works on or may lead complex projects of large scope. Projects may have significant and long-term impact. Provides solutions which may set precedent. Independently determines method for completion of new projects. Receives guidance on overall project objectives. Acts as a mentor to less experienced colleagues. Anticipated salary range :$105,100 - $150,100 Bonus eligible : Yes Benefits : Cardinal Health offers a wide variety of benefits and programs to support health and well-being. Medical, dental and vision coverage Paid time off plan Health savings account (HSA) 401k savings plan Access to wages before pay day with myFlexPay Flexible spending accounts (FSAs) Short- and long-term disability coverage Work-Life resources Paid parental leave Healthy lifestyle programs The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity. Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law. #J-18808-Ljbffr Cardinal Health, Inc.