Nurse Consultant, Scientific Pre-Market And Post Market Medical Device Reviewer
CurrentCurrent position with FDA/CDRH Office of Regulatory Programs. Work in Allegations of Regulatory Misconduct team reviewing medical device allegations. Previous; Senior Lead scientific reviewer of medical devices in the general hospital medical device branch at the FDA. Pre-Market device reviews include: 510k-new device, Investigational devices and combination product applications. Post-Market device reviews include: MDR analyst for 54 product codes, lead reviewer for recalls and allegations/complaints, combination product adverse report reviews. Active on standards committees for hospital beds and incubators. Member of the US hospital bed expert working group.