Khatereh R. Calleja, Member, CLSI

Khatereh R. Calleja, JD

Member, CLSI

Senior Vice President of Technology and Regulatory Affairs, AdvaMed

Khatereh Calleja, JD, is Senior Vice President of Technology and Regulatory Affairs for AdvaMed, the Advanced Medical Technology Association. AdvaMed is the world’s largest association representing manufacturers of medical devices, diagnostic products, and medical information systems. In that role, she works on a variety of device regulatory issues and also leads the Association’s diagnostics technical working groups, including the Diagnostics Task Force, Personalized Medicine and Molecular Diagnostics Working Group, and Diagnostics Standards Subteam.

Ms. Calleja joined AdvaMed’s Technology and Regulatory Affairs Department in December 2007, as the US Food and Drug Administration (FDA) was embarked on implementing provisions of medical device user fee legislation to support innovation and improve the device regulatory review process. Since that time, she also played an instrumental role in assuring appropriate implementation of key device provisions in the FDA Safety and Innovation Act and FDA Reauthorization Act of 2017, as well as developing initiatives to promote the public health and support access to timely and high quality diagnostic technology.

Ms. Calleja has an extensive policy, regulatory, legal, and government affairs background in health, device, and diagnostic issues. She previously served as federal affairs manager and established a Washington office for the American Society of Plastic Surgeons. Before that, Ms. Calleja directed legislative and regulatory affairs outreach activities at the American Academy of Otolaryngology—Head and Neck Surgery, in Alexandria, Virginia. She has also provided strategic consulting for the pharmaceutical industry, health care professional groups, and Fortune 500 companies.

Ms. Calleja is a graduate of Emory University and Villanova University School of Law.