Evangeline Loh, Emergo MDR expert

Loh, PhD, RAC

Global Manager, Regulatory Affairs

Evangeline Loh holds one of the most senior positions in the Emergo by UL consulting group and has over 15 years of global regulatory experience. Her background includes compiling European Technical Files and Design Dossiers; European Technical File reviews and gap assessments; borderline classifications; and 100+ peer reviews of Technical Files, including Clinical Evaluation Report reviews and responding to Notified Body findings. She specializes in borderline classification assessments, global vigilance, and global regulatory strategy. As the Global Regulatory Manager, Evangeline manages Emergo by UL's in-country representation services, including EU Authorized Representative, US Agent, and Australian Sponsor, and oversees global vigilance activities for these clients. She also supervises a team of international consultants and reviews dozens of device submissions and clinical evaluation reports each year. Prior to Emergo by UL, she held positions at Cook Incorporated and The Association of American Medical Colleges. Evangeline holds a PhD in pharmacology from The University of Texas Health Science Center at San Antonio and studied microbiology at Cornell University. She joined Emergo by UL in 2007.