Regulatory Affairs Manager – Labeling

🕒 August 18

🌽 Illinois, Ohio, +2 more states – Remote

🌽 Illinois – Remote 🏈 Ohio – Remote 🍂 Massachusetts – Remote 🏰 Missouri – Remote

💵 $105.1k - $150.1k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

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Cardinal Health

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1971

📦 Logistics

🏭 Manufacturing

🏥 Healthcare

💰 $78M Post-IPO Debt on 2006-08

Logistics • Manufacturing • Healthcare

Cardinal Health is a global healthcare services and products company. It provides a comprehensive range of healthcare services, including medical supply distribution, pharmaceutical distribution, and logistics solutions to various healthcare facilities such as hospitals, community health centers, and ambulatory surgery centers. Additionally, Cardinal Health offers a variety of medical products and pharmaceutical services. The company also focuses on innovative solutions to enhance healthcare delivery, through services like patient support, pharmacy management, and advanced therapy solutions. Cardinal Health is committed to supporting healthcare providers in delivering quality patient care while optimizing operational efficiency.

📋 Description

• Develop, implement, and maintain a harmonized global labeling strategy across product lines and markets • Manage the full labeling lifecycle, including creation, review, approval, and maintenance of labeling content and artwork within a controlled Quality Management System • Monitor global regulatory developments and assess their impact on product labeling • Ensure product labeling complies with FDA, EU MDR/IVDR, and other international medical device regulations • Lead implementation and maintenance of Unique Device Identification requirements across global markets • Oversee use of harmonized symbols, safety warnings, contraindications, and required labeling content • Manage country-specific labeling requirements, including translations, local health authority marks or logos, and formatting or content mandates • Ensure correct application of environmental symbols and marks for WEEE, battery directives, recycling, and packaging materials • Manage labeling disclosures and warnings related to REACH, RoHS, California Proposition 65, and EU MDR • Develop strategies for emerging requirements such as PPWR, repairability scores, and electronic or digital labeling • Collaborate with R&D, Packaging Engineering, Supply Chain, Marketing, and Graphic Designers on compliant labeling and artwork • Integrate labeling controls into quality processes including design controls, change control, risk management, and supplier management • Act as a mentor to less experienced colleagues and lead complex projects

🎯 Requirements

• Bachelor’s degree in scientific, engineering, life sciences, or related field is preferred or equivalent work experience • Advanced degree or Regulatory Affairs Certification (RAC) is a plus • 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 creation and management of labeling content, IFUs, and artwork in a regulated environment, preferred • Experience interpreting and applying environmental regulations such as REACH, RoHS, WEEE, and 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, preferred • Exceptional attention to detail • Ability to anticipate regulatory trends and develop proactive long-term compliance strategies • Strong organizational and project management skills • Proven ability to lead through influence, build consensus, and drive decisions across diverse, cross-functional teams • Ability to apply ISO 14971 risk management principles to the labeling process • Excellent written and verbal communication skills • Knowledge of FDA 21 CFR 801, EU MDR/IVDR GSPRs Chapter III, ISO 15223-1, and ISO 7000 • Knowledge of UDI requirements and global medical device and environmental labeling regulations

🏖️ Benefits

• Bonus eligible • 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