Bob has over 32 years of experience in regulatory and product development for the medical device and biopharmaceutical industries. He brings deep knowledge in developing and executing regulatory, clinical, and product development strategies; interfacing with regulatory agencies; and, filing regulatory submissions. He led an effort to reach agreement with the FDA and European Regulatory Agencies on a new clinical endpoint for a Phase 3 trial that significantly reduced product development time and cost.

    Bob has filed and received clearances on numerous regulatory submissions for implantable devices and therapies for cancer, kidney disease, pulmonary arterial hypertension, and acute pain management. He ran development from concept to market release of a complete line of endovascular AAA stented grafts (Class III), and expanded PTFE vascular grafts for use in peripheral arteries (Class II).

    He holds a BS from the US Military Academy, West Point, NY, a M.Eng. from UC Berkeley, and a Regulatory Affairs Certification (RAC).