Roberto F Refeca
Director, Regulatory Affairs @Edwards Lifesciences
Signup · Get unlimited contacts
WORK HISTORY
Director, Regulatory Affairs @Edwards Lifesciences
Edwards Lifesciences via the Acquisition of Endotronix, Inc, 2024:• RA Responsible for Original EU MDR CE Marking Submission for Class AIMD• Develop and Manage Relationships with External Regulatory Bodies including EU Notified Body• Develop and Maintain Relationships with Internal Business Partners and Key Stakeholders to ensure Business and Regulatory Objectives (Marketing, Quality, R&D, Manufacturing and Operations)• Maintain up to date Knowledge of Regulatory Requirements• Create, Implement, and Track Progress of Ongoing Projects including Regulatory Submissions• Review, Evaluate, Analyze, and Recommend/Provide Regulatory Actions/Solutions to Regulatory and Business Issues• Incremental RA Responsibilities for FDA: Class Active Implant (Post Approval Supplements)
EDUCATION
University of Miami Herbert Business School
Masters of Business Administration, Business Administration and Management, General
Maryville University of Saint Louis
Bachelor's degree, Biology/Biological Sciences, General
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.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.