Arthur Simonetti

Experience

• 

  United States Air Force

  Jul 1977 - Aug 1984

  Medic

  Senior Lead, ACLS Instructor, Code response team, and the ED was an exceptional learning opportunity, but can be fatiguing. The biggest joy was a successful resuscitation. Was prepped to enter the PA program, but opted for discharge to pursue another opportunity instead of going to Turkey for 3 years unaccompanied.

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  HealthSouth

  May 1995 - May 1999

  HIM Manager, QC, Patient Advocate

  I started as an Intake Coordinator in the Outpatient Dept and promoted to a key management position, overseeing medical records, quality control, patient advocate, risk analysis reporting and a member of Management Counsel.

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  AMERX Health Care

  Jun 1999 - now

  I performed multiple duties for a start-up company with initially 5 mangers, 6 SKU’s, and annual sales of $150K in 1999. Even though 9/11 hurt that fiscal year, difficult decisions had to be made. Since that time, we achieved $4M in sales in 2017 with a staff of 11 and 23 SKU’s, which confirmed that the decisions we made on our short-term and long-term goals were spot on. I assisted with new product development, design, writing of the Clinical Trials and Case Series for various types of wounds and treatments. The protocol, in my opinion, is the most challenging document of the medical device 510k. This requires a team effort and I made sure that inter-departmental communication was paramount. The IRB comes in a close second since more individuals are involved. I worked with several Universities on IRB submissions and utilized a third-party statistician who provided the sample size required. I worked with various Governmental agencies such as the FDA, GSA, DoD, CMS, and other regulatory entities. I was responsible for obtaining governmental agreements, such as the VA FSS and the DoD DAPA in order to sell our products to government and military entities. Very active working with marketing in performing product analysis, viability, and pricing in preparation of a product launch and short/long term goals. As the assistant QC manager, I reviewed all company policies and procedures, maintaining them as living documents. Oversaw the incoming inventory paying attention to product and packaging counts were accurate and damage documented. Show less

  • Director of Clinical & Regulatory Affairs

    Jun 1999 - now

  • Dir. Clinical & Regulatory Affairs

    Jun 1999 - Dec 2017