Regulatory Affairs Manager - IL Licensed

Job Summary

Seeking a detail-oriented Regulatory Affairs Manager - IL Licensed to lead the Global Labeling Compliance program in a full-time capacity, focusing on the end-to-end management of medical device labeling, packaging, and digital assets to ensure compliance with international regulations.

Key Responsibilities

• Develop and maintain a harmonized global labeling strategy, ensuring compliance across all product lines and markets
• Manage the entire labeling lifecycle, including creation, review, approval, and maintenance of labeling content within a controlled Quality Management System
• Monitor global regulatory changes and assess their impact on product labeling to ensure adherence to medical device and environmental regulations

Required Qualifications

• Bachelor's degree in scientific, engineering, life sciences, or related field; advanced degree or Regulatory Affairs Certification (RAC) preferred
• 7-10 years of experience in a Regulatory Affairs role within the medical device industry, specifically in global medical device labeling
• Experience with environmental regulations such as REACH, RoHS, and WEEE as they relate to product labeling
• In-depth knowledge of labeling requirements for major global markets, including the US, EU, Canada, Japan, and Australia
• Strong organizational and project management skills to handle multiple labeling projects across various product lines and regions