Roberto F Refeca

Background

About Roberto F Refeca

Over 20 years of professional experience within the medical space focused on Regulatory Affairs and Global Quality and Regulatory Compliance covering: US 510K, US PMA, US IDE; Canada Class II, IV and Clinical Trials; Latin America (LATAM) including Argentina, Brazil, Colombia, Costa Rica, Mexico; CE Mark (Directives and MDR/IVDR); EU Non Member States including Russia, Israel, Saudi Arabia; and Asia Pacific (APAC) including Australia, China, Japan, S. Korea. Product lines managed range from Class I-Class IV Devices Globally, including: Implants (Neurovascular, Cardiovascular, Peripheral, and Active Implantable Medical Devices (AIMD); Companion Diagnostics (CDx); Respiratory Health Devices, Digestive Health Devices, and General Hospital/General Surgical devices that include Surgery and Infection Prevention Products (Surgical Masks, Surgical Respirators, Surgical Gowns and other Class I/II Devices. Dedicated experience leading teams to successful outcomes and delivering Regulatory Clearances based on planned Regulatory Strategies. Direct experience interacting with Regulatory Agencies including: US FDA, Notified Bodies, Health Canada, Australia-TGA and Costa Rica MOH, including planning and coordinating Agency Meetings. Direct experience supporting audits: FDA, Notified Body, MDSAP, Brazil GMP. Experience working in a matrix organization within small/start up and multinational companies.