Management Team

Consultant, Regulatory Affairs

Mark Smutka

Mark Smutka has over 30 years of experience in regulatory affairs, clinical affairs, and quality assurance in the medical device industry. He has been working as a consultant since 2004 and has worked with a wide variety of medical technologies including treatments for atrial fibrillation and other arrhythmias, chronic back pain, obesity, and abdominal aortic aneurysms, and including devices such as vascular stents, vascular closure devices, heart valves, implantable pacemakers and defibrillators, ECG monitoring systems, robotically assisted surgical devices, renal denervation systems, arthroscopic surgical devices, and several other technologies.

Prior to and in conjunction with the consulting experience, he held management positions at Relievant Medsystems, AccessClosure (acquired by Cardinal Health), Flowmedica, Atrionix (acquired by Johnson and Johnson), Arthrocare, Arterial Vascular Engineering (acquired by Medtronic) and Telectronics Pacing Systems.

Mark has a Bachelor of Elected Studies degree from the University of Minnesota with a major field of psychology as well as significant work in the graduate Biometry program at the School of Public Health, University of Minnesota.

Mark Smutka Headshot

Mark Smutka

Consultant, Regulatory Affairs