I Am ORA Profile: Melinda Ruiz, PA-C
Melinda Ruiz, certified physician assistant, recall coordinator/compliance officer, Office of Medical Device and Radiological Health Division 1/East, Office of Regulatory Affairs, Food and Drug Administration
I am Melinda Ruiz, a commander in the U.S. Public Health Service and a recall coordinator and compliance officer in the Office of Regulatory Affairs (ORA). As a recall coordinator in the devices program, when FDA determines that a misbranded or adulterated medical device product poses a public health risk, I ensure that it is removed from the marketplace or corrected as quickly and efficiently as possible. I work to continuously develop and implement a system for assigning and monitoring field actions and our division’s training program for medical device recalls.
As the primary expert on recalls for Division 1 East for the Office of Medical Devices and Radiological Health, I work with our team to resolve the most difficult, controversial, and complex recall problems. These often pose a combination of scientific and regulatory challenges. My duties include acquiring information from industry about the production and problems associated with each. Working in FDA, I enjoy being part of a diverse team with members of various disciplines who come together to promote public safety. I enjoy the opportunities available to me to take on contributory, collateral duty roles with the Office of Strategic Planning and Operational Policy, the Center for Devices and Radiological Health, Center for Drug Evaluation and Research on the development of national procedures.
Before I joined the FDA 10 years ago, upon being commissioned as a U.S. Public Health Service Officer, I had the honor of serving some of our nation’s most vulnerable groups with the U.S. Department of Justice/Federal Bureau of Prisons and the U.S. Department of Homeland Security/Immigration Health Service Corps as a certified physician assistant. The five years I spent in the field of correctional medicine humbled me and allowed me to seek out unique opportunities to further serve my community and those in the greatest need. I prospered and currently serve my county as a sexual assault forensic examiner during evening hours after my FDA duties are finalized for the day.
I am very honored to be the 2019 ORA Recall Coordinator of the Year. I am Melinda Ruiz and #IAmORA.