Michael Nilo

Contact Details


I am currently working as an independent contractor available for consulting assistance with FDA processes. I am an accomplished biomedical engineer with extensive knowledge of FDA regulations. I have worked with a regulatory group attempting to launch innovative vascular interventional products in the US Market. Previously, I worked in the Office of Device Evaluation at the FDA and examined pre-market submissions for cardiac medical devices, specifically devices that are inserted into the coronary arteries and the devices used in the interventional procedure. Drug eluting stents, atherectomy systems, percutaneous transluminal coronary angioplasty balloons, guide catheters, and embolectomy catheters are just a few of the devices that I was responsible for reviewing. Previously, I reviewed dental devices such as implants, abutments, bone-grafting materials, bone plates, and trans-mandibular joint implants.


University of Alabama at Birmingham
Birmingham, Alabama, United States
Biomedical Engineering
2007 To 2009
Dissertation: Mechano-dependent regulation of TGF-β1 in Aortic Valve Interstitial Cells
Advisor: W. David Merryman, PhD

University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Bioengineering, Chemistry
2003 To 2007

Job History

Senior Regulatory Affairs Consultant
December 2016 - present

November 2016 - present

Senior Regulatory Affairs Specialist
Lake Oswego, OR, United States
June 2015 - October 2016

Lead Reviewer / Biomedical Engineer
White Oak, MD, United States
November 2009 - May 2015

Product Interests

  • Biomaterials
  • Biotechnology
  • Combination Products
  • IVDs
  • Medical Devices