Mr. Jensen has more than 28 years of experience leading successful quality and regulatory affairs teams at several U.S. companies. Prior to joining Alucent, he has provided regulatory and quality leadership for such diverse products as embolism catheters, vascular catheters, ophthalmic equipment, active wound care devices, ozone sterilization products, x-ray equipment, electrosurgical equipment and robotically-assisted surgical systems and accessories.
He has created, operated and maintained quality management systems compliant with US, EU, Canadian and Japanese medical device regulations which were all successfully audited by the respective regulatory agencies. He has also helped medical device companies receive market clearance in these same regions. He has written over a dozen successful 510(k)s and numerous other submissions to FDA, EU, Canada and Japan.
His education includes a Bachelor of Science in Electrical Engineering from Utah State University, and a Masters of Science in Applied Mathematics from Johns Hopkin