Caroline Miceli

About Caroline Miceli

I am a global regulatory professional. My experience includes Pre-Market Approval or PMA (Class In-Vitro diagnostic (IVD) products, Pre-Market Notifications or 510(k) medical devices, EU/International Registration support, FDA Establishment Registration & Listing, Advertising and Promotion, FDA UDI/GUDID, GMDN and FDA Imports. R&D experience includes development of IVD assays to detect various disease states or conditions thus allowing for further medical interventions such as drug therapies and/or surgical procedures.

Experience

1. Manager Regulatory Affairs

   Cardinal Health

   Feb 2015 — Present · Waukegan, IL

   My role at Cardinal Health includes a diverse medical device product line and several regulatory functions. My experience here has included the following medical device products: surgical gloves, surgical gowns, isolation gowns, surgical face masks, other medical apparel, wound drains, convenience kits, IVD’s, laboratory supplies/equipment, and fluid management. Global regulatory functions include review/approval of design change control, product labeling, FDA 510(k) submissions, and advertising/promotional review.

Education

• Regulatory Affairs Professional Society (RAPS)

  Certificate, RAPS Medical Devices-Pharmaceuticals Dual Certificate Program

• Argonne National Laboratories

  Undergraduate Research Participant, Radiological and Environmental Research Division, Argonne, IL

• Carthage College

  Bachelor's Degree, Biology with a minor in Chemistry