Worlanyo Sosu-Sedzorme
Adjunct Faculty, Ms Regulatory Affairs Graduate Program @The George Washington University School of Medicine and Health Sciences
Signup · Get unlimited contacts
WORK HISTORY
Adjunct Faculty, Ms Regulatory Affairs Graduate Program @The George Washington University School of Medicine and Health Sciences
Washington, DC, US
EDUCATION
Simon Fraser University
MSc, Molecular Biology and Biochemistry 2004
UNIVERSITY OF SCIENCE AND TECHNOLOGY
BSc (Hons), Biological Sciences
Kwame Nkrumah University of Science and Technology, Kumasi
BSc, Biological Sciences
The George Washington University
Postgraduate Certificate, Clinical Research Administration 2009
ABOUT WORLANYO SOSU-SEDZORME
Certified regulatory and quality assurance professional with expertise in IVD and medical device development, regulatory strategies and submissions, software and cybersecurity regulatory framework, privacy, laboratory-developed tests, CLIA and CAP policies, quality system, electronic document management system, quality system audits, vigilance, and recalls. Thorough knowledge of ICH/GCP, GLP, drug and biologics development, clinical research, SaMD, IND, NDA, and PMA. Regulatory submissions to FDA, Notified Bodies, Health Canada, US Clinical Laboratory Improvement Amendment (Federal and State), College of American Pathologists (CAP). Experience in leading and hosting regulatory inspections.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.