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Regulatory Affairs Manager - IL Licensed

VirtualVocations

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

Vacancy posted 8 days ago
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