Carol Alloian

WORK HISTORY

ABOUT CAROL ALLOIAN

A versatile proven Regulatory & Quality Leader with a passion for building robust global regulatory infrastructure, teams, and strategies - and implementing. As a strategic problem solver and cross functional bridge builder, I enjoy partnering with stakeholders to architect solutions that successfully navigate complex emerging regulatory, customer & industry needs. Extensive experience across many types of Medical Device & IVDs - including Infectious Disease/ Toxicology/ Cardiometabolic IVDs, SaMD, Equipment, core histology, digital pathology & cytogenetic laboratory equipment & accessories, Renal Devices, Drug Delivery Devices, Combination Products, Biologics, Cardiovascular Systems/Devices/ Accessories, EMR/ EHRs, PACS/ CVIS, Surgical Navigation Equipment, Imaging Systems (MRI, CT, C-Arms, other), personal healthcare/ fitness devices Expertise in Product Development & Global Launch; Global Compliance Strategy; Global Device Labeling; Global Advertising & Promotion; Regulatory Intelligence & Advocacy; Global UDI, Serialization; EU MDR/ IVDR; Regulatory Master Data Management/ Regulatory System Management Specific Expertise includes; • Global Pre-Market Strategy, including submissions, compliance and labeling requirements • Global UDI Strategy and Implementation • EU MDR/IVDR Strategy and implementation, especially EUDAMED, Labeling, and EU UDI • Capturing and converting Global Regulatory Intelligence to effective strategies and actions • Global Regulatory and Product Master Data Management strategies, solutions and governance • Global Advertising and Promotion • Effective Team Builder and People ManagerDue Diligence • Quality Management Systems Implementation and Remediation • Lead Quality System Auditor