Caroline Rhim
Founder and Principal Consultant at Evera Regulatory Advisors, Llc
Based in Raleigh-Durham-Chapel Hill, United States
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Seniority
C-Team
Department
General Business & Management
Location
Raleigh-Durham-Chapel Hill
Industry
Medical Equipment Manufacturing
Company size
1 to 10
Contact information
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c•••••••@everareg.com
Phone
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Background
About Caroline Rhim
Regulatory professional with over 20 years of experience in the life sciences and medical device industry, including FDA experience in Center for Devices and Radiological Health (CDRH); Expertise in navigating regulatory pathways from premarket to postmarket, including device classification and preclinical as well as clinical study design; Can advise across a broad variety of technologies that span 510(k), De Novo, investigational device exemption (IDE), and premarket approval application (PMA) regulatory pathways; Strong internal network at FDA with the ability to effectively communicate with regulatory counterparts.
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