Robert has over 25 years of medical device RA/QA experience and has significant RA experience with successful 510 (k) & PMA submissions, FDA interactions, QMS experience with over 10 years of leadership insight. Join us for an interesting conversation on the regulatory submission pathway, the differences between the 510 (k) and PMA processes, key items to consider when interacting with the FDA and governing bodies as well as some insights on leadership and proactivity.
Robert holds a double bachelor of arts in International Economics and Russian Language from the University of Texas at Austin. After six years of foreign policy/defense/intelligence work for the US Congress in Washington, Robert moved into the...
Darwin understands the key qualities that companies look for in candidates to grow market share while enhancing their positive culture and team environment. He has a clinical background of over 20 years, including 15 years of sales experience...