A dynamic executive with extensive global experience in successfully implementing creative regulatory and clinical strategies from development through commercialization. Experience in multiple therapeutic areas including Endoscopy, Orthopedics and Gastroenterology and Metabolic Diseases. Recognized for taking a hands on approach while building high performance teams to support company growth. Experienced in successfully developing, leading and implementing complex plans and directing successful regulatory filings. Results driven manager with the ability to adapt and anticipate changes in plan execution. EXPERTISE• Global Regulatory Strategy • Executing US Pre-Sub, IDE and 510(k) submissions • Early and mid-stage start ups • Strategic and tactical implementation of clinical initiativesREGULATORY ACHIEVEMENTS• Coordinated and led the successful approval of multiple IDEs • Developed and executed successful strategies that led to early CE Mark approvals for class II and III devices • Successfully navigated worldwide approvals for initiation of pre and post-market clinical trials in US, EU, Canada and South America• Negotiated and completed over 40 510(k) submissions that led to successful market launchCLINICAL STRATEGY AND IMPLEMENTATION• Built a clinical operations team to support execution of 350 patient trial• Successful completion of OUS first in human trials to support procedural development efforts and establish acceptable safety profile• Integration of CMS recommended reimbursement measures into spinal stenosis trial that led to significant coverage of trial execution costs• Coordination of multiple clinical programs to support type 2 diabetes indication in the US and EU
Listed skills include U.S. Food And Drug Administration, Medical Devices, Regulatory Affairs, and Clinical Affairs.
