SENIOR REGULATORY AFFAIRS PROJECT MANAGER
Joined: July 10, 2024
I am a certified medical device professional with over 30 years experience. I have successfully achieved almost 70 FDA 510(k) clearances and 1 EUA during the pandemic. Some of the projects I have worked during my career have been trans-myocardial revascularization of the heart with a laser, orthopedic, urological, gastro-endoscopic, laparoscopic, dermatology & ENT laser systems, a surgical robotics system, an in-home kidney dialysis system, an ultrasonic ablation system for neurosurgery, a family of trans-jugular liver & percutaneous biopsy devices, catheters, spirometers, Specialty Needles (Brachytherapy, Ophthalmic, Suture, Tuohy, & Bone Marrow Biopsy), gastro-enteric feeding tubes, an intraoperative MRI system, a neonatal MRI system, SaMD-point of care ultrasound imaging of the heart using Artificial Intelligence, Emergency Medical Devices (a battlefield chest tube, a wound drainage device, suction Yankauers, wound clot dressings, a de-choking device, and an endo-trach placement device), as well as class 3 device implants. I am intrigued and passionate about medical device technology and its ability to help patients.