Caroline Miceli is a seasoned global regulatory professional currently serving as the Manager of Regulatory Affairs at Cardinal Health. In this pivotal role, Caroline oversees a diverse portfolio of medical device products, including surgical gloves, gowns, face masks, and in-vitro diagnostic (IVD) assays. Her extensive...
Caroline Miceli is a seasoned global regulatory professional currently serving as the Manager of Regulatory Affairs at Cardinal Health. In this pivotal role, Caroline oversees a diverse portfolio of medical device products, including surgical gloves, gowns, face masks, and in-vitro diagnostic (IVD) assays. Her extensive expertise encompasses critical regulatory functions such as Pre-Market Approval (PMA) for Class III IVD products, Pre-Market Notifications (510(k)), and comprehensive EU and international registration support. Caroline's proficiency in navigating complex regulatory landscapes is further demonstrated through her involvement in FDA Establishment Registration & Listing, advertising and promotion compliance, and the management of FDA Unique Device Identification (UDI) and Global Unique Device Identification Database (GUDID) submissions.
At Cardinal Health, Caroline leads key projects aimed at ensuring compliance and facilitating market access for innovative medical devices and laboratory supplies. Her role also encompasses the development and execution of regulatory strategies that align with both domestic and international standards, including ISO 13485. Caroline's background in research and development enhances her ability to contribute to the lifecycle management of products, particularly in the design control of IVD assays. With a keen understanding of the regulatory environment and a commitment to advancing healthcare solutions, Caroline Miceli is a vital asset to Cardinal Health, driving initiatives that not only meet regulatory requirements but also enhance patient safety and product efficacy in the ever-evolving landscape of the life sciences industry.
