Joe Schwoebel

Current

Vice President, Regulatory Affairs at InSet Technologies

Education

University of Miami - School of Business
Pennsylvania State University - University Park Campus

Connections

184 connections

Industry

Medical Devices

Websites

Joe Schwoebel’s Summary

Expert in Medical Device Regulatory Affairs and Clinical Studies, including strategic plans, clinical protocols, and FDA submissions such as IDEs, PMAs and 510(k)s. Completed 12 multi-site clinical studies and obtained FDA release of over 100 products. Strong record of domestic and international regulatory success.

With clinical studies, I developed clinical study plans, recruited investigators, obtained IRB approvals, enforced study compliance, prepared progress reports, and controlled budgets. From a compliance perspective, I implemented programs for Protection of Human Research Subjects, Good Laboratory Practices, cGMP/QSR (ISO 13485:2003), European Medical Device Directive, and Medical Device Reporting. Experience with pre-clinical biocompatibility studies, Class III implantables, transcutaneous devices and sterility assurance.

Joe Schwoebel’s Experience

Vice President, Regulatory Affairs

InSet Technologies

(Medical Devices industry)

September 2008 — Present (1 year 4 months)

Joe Schwoebel’s Education

University of Miami - School of Business

MBA , Management and Information Technology , 1978 — 1980
Pennsylvania State University - University Park Campus

BSEE , Biomedical Engineering

Activities and Societies:

Eta Kappa Nu
Outdoors Club
Amateur Radio Club

Additional Information

Joe Schwoebel’s Websites:

Joe Schwoebel’s Groups:

Regulatory Affairs Professional Society (RAPS)
Int'l Society for Technology in Education (ISTE)
Eta Kappa Nu - Engineering Honorary Society
Pittsburgh Technology Council - Biomedical Council
Southeast Medical Device Association (SEMDA)
University of Miami Alumni Association
Penn State University Alumni Association