Evangeline Loh, Ph.D. - Director of Regulatory Affairs

Dr. Loh oversees regulatory consulting support for Emergo clients worldwide. In this role, she provides a wide variety of consulting support to clients including Technical File and Design Dossier preparation, CE Marking consultation, risk analysis consulting, classification determination and US FDA 510(k) preparation.

Prior to joining Emergo Group, Dr. Loh managed regulatory affairs for the surgery and critical care units of Cook, Inc., one of the largest manufacturers of needles, stents, catheters and wire guides. She has extensive knowledge of US and EU regulations and in addition to working on regulatory submissions for the US and EU, she has worked on regulatory submissions in Canada, Korea, Taiwan, Japan, China and Hong Kong.

EXPERIENCE:

Regulatory Affairs Scientist, Cook Inc. (2004-2006)

• Managed all regulatory affairs responsibilities for two business units (Surgery and Critical Care) and additional product development teams.
  
• Submitted regulatory applications to market medical device products originating from those groups, which includes combination medical devices incorporating medicinal substances, such as various coated stents and catheters.
  
• Developed regulatory strategy to guide the design team towards successful regulatory approvals/clearances/registrations.
  
• Contributed to successful medical device regulatory submissions and responses to questions appropriate for regulatory bodies in the U.S., EU, and around the world, such as in Canada, Korea, Hong Kong, Taiwan, and China.
  
• Successfully submitted U.S. Special 510(k) applications, EU Technical Files and Design Dossiers for CE Marking, and registrations in many nations.
  
• Lead the regulatory activities to expand registration of our products into the Korean market.
• Implemented company wide template for consistent regulatory submissions in Standard Technical Documentation (STED) format, Korean Technical File submissions, and Hong Kong registrations for the Regulatory Affairs Department, to minimize work and improve the chances of success.
  
• Served as lead for randomized blind clinical investigation in pediatric cardiovascular patients.
  
• Reviewed marketing and advertising pieces for regulatory sign-off.
  
• Researched and drafted clinical background documents about various medical procedures or devices.

Staff Associate II, Biomedical Sciences Division, Association of American Medical Colleges (2002-2004)

• Researched issues related to industry sponsored clinical trials in academic settings: contract negotiations, data metrics, Good Clinical Practice (GCP) training, International Conference on Harmonization (ICH), GCP, and Code of Federal Regulations (CFR) regulations, and Institutional Review Boards (IRB).
  
• Developed data metrics and quality control measures and conduct statistical analysis to evaluate the performance of multiple and individual sites.
  
• Functioned as liaison between researchers at the clinical centers and industry representatives, plan quarterly meetings, coordinate projects, and draft correspondences.
  
• Organized and managed program of national conference on perspectives about clinical trials and secure Continuing Medical Education (CME) credit for conference attendance.
• Managed a large professional development program Group on Graduate Research Education and Training (GREAT Group) for biomedical science research education deans and faculty members affiliated with academic medical colleges.
  
• Served as liaison with all the constituents regarding all aspects of the program and directing all member services: oversee database, disseminate information on listserve, and maintain Web site. Research and evaluate current issues and topics, identify important topics by discussion with experts in the field, conduct and analyze results from the studies, and write reports on the conclusions for the membership.
  
• Developed agendas for the Steering Committee and planned the annual national meeting. Review and prepared recommended funding for operating budget, approve and track expenditures, schedules, and evaluate effectiveness of spending.
  
• Prepared and disseminated testimony, statements, letters, position papers, and issue briefs on policy topics, and monitor activities of federal agencies, independent policy organizations, news media, scientific societies, and others that relate to the areas under study.

Research Assistant, Department of Pharmacology, University of Texas at San Antonio (1997-2001)

• Designed and implemented experimental research protocols to characterize a novel glycoprotein hormone like G-Protein Coupled Receptor (GPCR) using molecular techniques for research thesis project.
  
• Prepared different samples of DNA repeatedly until the quality was pure enough to achieve the desired results.
  
• Isolated uncontaminated DNA samples, amplified required DNA, and incubated DNA with cells to produce cells that express the receptors on the surface of the cell.
  
• Experimented with multiple research methods.

Undergraduate Research Assistant, Department of Nutrition, Cornell University (1994-1995)

• Followed protocols to assess effect of lead exposure in rats on different cognitive tests.
  
• Shared data at weekly lab meetings to analyze for anomalies.

Undergraduate Research Assistant, Hybritech Corp. (1991-1992)

AREAS OF EXPERTISE:

QA & RA:

• CE Marking
• Medical Devices Directive (93/42/EEC)

Devices:

• Stents
• Wire guide
• Catheters
• Needles
  

CERTIFICATIONS:

• Regulatory Affairs Professional Society, RAC (US, EU) designation

EDUCATION:

• Bachelor of Science in Microbiology, College Agriculture and Life Sciences, Cornell University.
• Ph.D. in Pharmacology, University of Texas Health Science Center at San Antonio.

HOME BASE:

• Texas, USA