Regulatory Affairs Team

The Regulatory Affairs Team at Second Heart Assist Inc. is responsible for navigating and ensuring compliance with complex regulatory requirements to bring the company's minimally invasive circulatory support technologies to market. This team coordinates with the FDA and other regulatory bodies, manages pre-clinical studies, oversees quality management systems, and communicates with investors regarding regulatory milestones and impacts. Their work ensures that Second Heart's innovative cardiac assist pumps meet all necessary standards for safety and efficacy, ultimately facilitating successful product approvals and launches.