- Principal Regulatory Affairs Policy & Advocacy Specialist, Medtronic
Amra Racic is currently employed at Medtronic as a Principal Regulatory Affairs Policy and Advocacy Specialist. She has been in the healthcare industry for over 16 years, the majority spent with the Medtronic regulatory group doing a variety of US FDA and international submissions for low risk, high risk and in-vitro medical devices. Prior to Medtronic, she has also worked on regulatory submission projects at Bayer AG and also had responsibility for patient care management at a local hospital in Minneapolis.
Prior to moving into her current role, Amra spent a couple of years working in the corporate group at Medtronic tracking and interpreting worldwide new and changing regulations. She has led internal teams of experts through various exercises of assuring compliance to a variety of global regulatory requirements.
Today she primarily focuses on identifying, leading and executing on Medtronic global regulatory advocacy initiatives through venues such as training of regulatory authorities, seminar presentations, development of position/white papers. Amra also heavily participates in trade association working groups, including the Advanced Medical Technology Association (AdvaMed) and various harmonization working groups.
Amra holds a B.A in Business Administration and an MBA with focus on Business Management from Walden University in Minneapolis.