Certus International

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Karen A. Wolfe-Kerker, MS, RAC, CCRA

Vice President, Regulatory Affairs



   B.S.                                                                     Health Sciences, Clinical Research Administration

                                                                              The George Washington University

                                                                              Washington, DC


   M.S.                                                                    Health Science, Clinical Leadership and Management

                                                                              The George Washington University

                                                                              Washington, DC


                                                                              Cardiac Ultrasound Training

                                                                              St. Luke’s Hospital

                                                                              St. Louis, Missouri


                                                                              Respiratory Therapy Registry Program

                                                                              St. Louis Community College – Forest Park

                                                                              St. Louis, Missouri


                                                                              University of Missouri

                                                                              Columbia, Missouri


Karen Wolfe-Kerker has over 30 years experience in healthcare, including over 20 years in the pharmaceutical and medical device industry.  Ms. Wolfe-Kerker has ten years of in-hospital patient care experience in respiratory therapy, cardiology and diagnostic cardiac ultrasound imaging.  Ms. Wolfe-Kerker is certified in U.S. regulatory affairs (RAC) by the Regulatory Affairs Professional Society and is certified as a Clinical Research Associate (CCRA) by the American Society of Clinical Research Professionals. She also maintained an active status as a Registered Diagnostic Cardiac Sonographer (adult echocardiography) from the American Registry of Diagnostic Medical Sonographers for numerous years, but has recently decided to retire that certification to concentrate on her current pursuits in regulatory affairs with Certus International.


Ms. Wolfe-Kerker has been Vice President, Regulatory Affairs at Certus International, Inc. since May 2013; previously she was Director of Regulatory Affairs since June 2006.  Prior to 2006, she was Senior Manager of Clinical and Regulatory Affairs from 2001 to 2006.  Ms. Wolfe-Kerker is responsible for managing and overseeing regulatory affairs and quality assurance activities, such as ensuring corporate regulatory compliance and managing FDA submissions such as IND applications, annual reports, safety reports and IND information amendments.  She is also responsible for FDA communications, managing formal meetings with the FDA, including developing and submitting meeting information packages to support meetings, participating in FDA meetings and assessing regulatory strategies for new product development.  She also participates in developing Standard Operating Procedures, manages client corporate compliance audits and performs clinical compliance audits.


Prior to joining Certus, Ms. Wolfe-Kerker worked as an independent consultant in the pharmaceutical and medical device industry, providing regulatory strategy and guidance to clients for oncology, cardiovascular and medical imaging drugs and medical devices, managing and monitoring clinical trials and auditing trial sponsor files and clinical sites. From 1992 to 1998, Ms. Wolfe-Kerker was a Senior CRA in Medical and Regulatory Affairs at Mallinckrodt Medical, Inc.