Expert Consultant with broad clinical and in-vitro clinical and industry diagnostics and medical and regulatory IVDR affairs experience. Recognized for leading global technical teams in third level technical support for knowledge transfer, regulation, and new product introduction. Technical leader with proven record with a focus on quality assurance, patient care, and customer satisfaction. • In Vitro Diagnostics Consulting• In Vitro Diagnostics Regulation (IVDR) Consulting• Medical Affairs Consulting• Clinical Chemistry • Marketing and logistics • Regulatory compliance• Diagnostics • Team development• Toxicology • Project management• Hospital Clinical Laboratory expertise • Budgeting • Market planning • Medical laboratory technology• Personnel technical training • in Vitro Diagnstics Assays development• Industry clinical experience • Problem-solving skills• In Vitro diagnostics manufacturing• Quality assurance • Bilingual in Spanish and English• Medical Interpreter Spanish and English• Medical Translator Spanish and EnglishAdditional Experience | DuPont Clinical Systems – Newark, DESenior Technical Support Specialist | Marketing Technical Support for diagnostic assays.Senior Technical Support Analyst | Developed clinical protocols for adaptations of the reagent kits Customer Support Specialist | Managed over 3,300 telephone troubleshooting calls International Technical Specialist | Global technical support and training Customer Training Specialist |Trained 5,000 customers in the operation of analyzers. Technical Services Specialist | Investigations of customer inquiries for assays for the DuPont analyzers.Contract Technical Translator | Translated English to Spanish and Spanish to English clinical protocols.Hospital Clinical Laboratory ExperienceClinical Chemist and Clinical Chemistry Laboratory Supervisor | Holy Cross Hospital in Ft. Lauderdale, FL. Chemistry / Blood Bank Technologist | State University of New York- Upstate Medical Center in Syracuse, NY. Chemistry / Medical Technologist | Fort Myers Community Hospital in Ft. Myers, FL.
Listed skills include Project Management, Process Improvement, Leadership, Program Management, and 44 others.