SUMMARY Senior Executive with combined technical, regulatory strategy, project management and business experience to build businesses and relationships to deliver new products to market. Over 20 years of experience in medical device, pharmaceutical, biologics, and diagnostic development, including In-Vitro Diagnostic, with market leaders such as Johnson & Johnson, Watson Pharmaceuticals and Mela Sciences. Led worldwide regulatory, quality, and clinical development programs. Well-organized problem solver and decision-maker leader with critical resources optimization and prioritization skills to achieve objectives. Strong interpersonal skills and goal oriented. * 510 (k)/IDE/PMA * Pharmaceuticals / Biologics / * Retrovirology * Immunology * FDA/MDD/IVD/EMEA Diagnostics / Medical Devices * Hematology * IND/NDA/BLA

Highlights:

• Management
• Manufacturing
• Product Development
• Risk Management
• Process Engineering
• Engineering
• Quality
• Quality Assurance
• Quality Control
• Regulatory
• Strategy
• Clinical Development
• Pharmaceutical
• Medical Device
• Green Belt
• PnL