Carla Sivak

Quality Assurance and Regulatory Consultant

As a consultant in the areas of Quality Assurance and Regulatory Affairs, Carla brings over twenty-five years of experience in medical device quality, regulatory and clinical affairs. She has spent her career conceptualizing and implementing global quality and regulatory strategies while balancing business needs with compliance risks. Strategically utilizing her background as a critical care nurse, educator and software developer, she uniquely facilitates communication and understanding between medical device manufacturers, their customers and regulators. Carla has held senior management positions in quality, regulatory and clinical in start-up and large corporate settings such as SynapDx, an early stage diagnostics company, Johnson & Johnson's DePuy Mitek business, Edwards Lifesciences' Critical Care and Cardiac Surgery businesses, Philips Home Healthcare Solutions, Bard Electrophysiology, Boston Scientific and, most recently, as Portal’s VP of Quality Assurance and Regulatory Affairs. Carla received her Masters in Computer Science from Fitchburg State University and her BS in Nursing from the University of California, San Francisco.