Regulatory Affairs Manager – Labeling

🔥 0 minutes ago

🌽 Illinois, Ohio, +2 more states – Remote

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

💵 $105.1k - $150.1k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

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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 entire 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 global medical device regulations and international standards • Lead implementation and maintenance of Unique Device Identification (UDI) requirements • Oversee correct use of harmonized symbols, safety warnings, contraindications, and required labeling content • Manage country-specific labeling requirements, translations, health authority marks or logos, and formatting mandates • Ensure environmental symbols, sustainability marks, and packaging material identification are correctly applied • Manage labeling requirements related to REACH, RoHS, WEEE, California Proposition 65, and EU MDR • Develop strategies for emerging requirements including PPWR, repairability scores, and electronic or digital labeling • Collaborate with R&D, Packaging Engineering, Supply Chain, Marketing, and Graphic Designers • Integrate labeling controls into design controls, change control, risk management, and supplier management processes • Participate in policy and procedure development and recommend new practices, processes, metrics, or models • Lead complex, large-scope projects and independently determine methods for completing new projects • Mentor less experienced colleagues

🎯 Requirements

• Bachelor’s degree in scientific, engineering, life sciences, or related field is preferred, or equivalent work experience • 7-10 years of experience in a Regulatory Affairs role within the medical device industry, preferred • Demonstrated experience in global medical device labeling, including labeling content, IFUs, and artwork in a regulated environment, preferred • Experience interpreting and applying REACH, RoHS, WEEE, and PPWR to product labeling requirements is desired • In-depth knowledge of labeling requirements for the US, EU, Canada, Japan, and Australia, preferred • Exceptional attention to detail • Ability to anticipate regulatory trends and develop proactive compliance strategies • Strong organizational and project management skills • Proven ability to lead through influence, build consensus, and drive decisions across cross-functional teams • Ability to apply ISO 14971 risk management principles to labeling • Excellent written and verbal communication skills • Advanced knowledge of relevant concepts, principles, and technical capabilities • Advanced degree or Regulatory Affairs Certification (RAC) is a plus

🏖️ 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 • Inclusive workplace that values diversity of thought, experience and background