Jeff Gensler Kindeva Drug Delivery

-Progressive Quality and Regulator Leader with high Business accumen including an MBA -FDA Audit leadership - Lead multiple audits - with no FDA 483 -Lead Multiple 510K submissions -Senior leadership experience -Multiple site management experience including management of internation sites -20 years of Quality Assurance Management experience. -15 years of Leading Medical Device Quality/Pharma Quality Assurance and Regulatory affairs including: Class I, II and III Medical Device Manufacturing Pharamaceutical Manufacturing International Registration including extensive knowledge of CE mark process, Health Canada and JPAL