Regulatory Affairs Manager – Labeling

Cardinal Health

Regulatory Affairs Manager leading Global Labeling Compliance for international medical device regulations. Ensures labeling adheres to complex compliance requirements while collaborating across functional teams.

Posted 6/29/2026full-timeWaukegan • Illinois, Massachusetts, Montana, Ohio • 🇺🇸 United StatesSeniorLead💰 $105,100 - $150,100 per yearWebsite

About the role

Key responsibilities & impact

Lead the end-to-end alignment of medical device labeling, packaging, and digital assets with evolving international regulations
Oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements
Manage the entire labeling lifecycle, including the creation, review, approval, and maintenance of all labeling content and artwork within a controlled Quality Management System
Proactively monitor the global regulatory landscape for any new or revised labeling requirements
Ensure all product labeling strictly adheres to global medical device regulations
Lead and manage the implementation and maintenance of Unique Device Identification (UDI) requirements on all applicable label and packaging levels across global markets
Act as the primary expert for all environmental and sustainability labeling requirements driven by global directives
Ensure the correct application of environmental symbols and marks
Act as a central hub for collaboration on all labeling matters

Requirements

What you’ll need

Bachelor’s degree in scientific, engineering, life sciences, or related field
Minimum of 7-10 years of experience in a Regulatory Affairs role within the medical device industry
Specific and demonstrated experience in global medical device labeling, including the creation and management of labeling content, IFUs, and artwork in a regulated environment
Experience interpreting and applying environmental regulations (e.g., REACH, RoHS, WEEE, PPWR) to product labeling requirements is desired
In-depth knowledge of labeling requirements for major global markets, including the US, EU, Canada, Japan, and Australia
Exceptional Attention to Detail: A meticulous and precise approach to reviewing and managing complex information is absolutely essential for this role
Ability to anticipate regulatory trends in labeling and develop proactive, long-term strategies to ensure compliance and mitigate risk
Strong organizational and project management skills to manage multiple, concurrent labeling projects across different product lines and regions
Proven ability to lead through influence, build consensus, and drive decisions across diverse, cross-functional teams
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
Excellent written and verbal communication skills, with the ability to clearly articulate complex labeling requirements to technical and non-technical audiences.

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Labeling Lifecycle ManagementUnique Device Identification (UDI)Risk Management Principles (ISO 14971)Labeling Content CreationIFU Management

Soft Skills

Strong Organizational SkillsExcellent Communication SkillsAbility to Build ConsensusLeadership Through Influence