Remy Serge Manzi Muhire
About Remy Serge Manzi Muhire
Remy Serge Manzi Muhire is a Senior Clinical Product Risk Specialist at Boston Scientific and an Industry Representative for the FDA's Gastroenterology & Urology Devices Panel. He has a diverse background in clinical research, epidemiology, and healthcare management, with extensive experience in managing complex clinical trials and international collaborations.
Senior Clinical Product Risk Specialist at Boston Scientific
Remy Serge Manzi Muhire has been serving as a Senior Clinical Product Risk Specialist at Boston Scientific since 2020. Based in Marlborough, Massachusetts, his role involves overseeing clinical product risk assessments, ensuring compliance with regulatory standards, and mitigating potential risks associated with medical devices. His expertise in clinical research and extensive background in epidemiology contribute to the effective management of product safety and quality.
Industry Representative at FDA
In 2023, Remy Serge Manzi Muhire took on the role of Industry Representative for the Gastroenterology & Urology Devices Panel at the FDA, based in Rockville, Maryland. His responsibilities include representing industry perspectives on regulatory issues, providing insights during panel discussions, and supporting the safe and effective use of medical devices within the sectors of gastroenterology and urology.
Education and Expertise in Public Health
Remy Serge Manzi Muhire has an extensive academic background in public health and medicine. He holds a Postdoctoral degree in Epidemiology from Johns Hopkins Bloomberg School of Public Health (2016-2018) and a Master of Public Health (MPH) in Applied Epidemiology from the same institution (2012-2013), complemented by a Certificate in Health Finance and Management. He also completed a Fellowship in Emergency Ultrasound at Harvard Medical School - Massachusetts General Hospital in 2012. Furthermore, he has a Bachelor's in General Medicine from the National University of Rwanda (2004-2009).
Clinical Research Experience
Remy Serge Manzi Muhire has amassed diverse clinical research experience across several esteemed institutions. He worked at Columbia University Irving Medical Center as a Clinical Research Officer and Ophthalmic Photographer (2019-2020), and at Wills Eye Hospital as a Clinical Research Coordinator and Drug/Medical Device Safety Specialist (2014-2016). He has also served as a Clinical Research Consultant and has managed complex Phase II-IV clinical trials, ensuring adherence to Good Clinical Practice (GCP) and ICH guidelines.
Professional Skills and Proficiencies
Remy Serge Manzi Muhire is proficient in numerous data management and analysis software tools, including ArcGIS, STATA, SPSS, and REDCAP. He has full professional proficiency in French, facilitating effective communication in international contexts. His career also showcases strategic planning and people management capabilities, leading to successful project execution in various healthcare environments. His roles have frequently involved building partnerships and engaging in policy advocacy with major organizations such as USAID/PEPFAR, CDC, NIH, and the World Bank.