Margeaux Rogers
Vice President, Regulatory Affairs @MCRA, an IQVIA business
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WORK HISTORY
Vice President, Regulatory Affairs @MCRA, an IQVIA business
Responsible for development of regulatory strategy and US and international regulatory submissions, regulation-compliant Clinical Evaluation Reports, comprehensive literature evaluations, manuscript submissions and other reports and assessments to support regulatory approval and compliance. • Drafting, reviewing, and strategizing US and international regulatory submissions including 510(k)s, PMAs, IDEs, Pre-IDEs, Technical Files, and Clinical Evaluation Reports• Review company labeling and clinical protocols for compliance with FDA regulations• Research new and updated medical device regulations in US and international countries• Perform predicate landscape and regulatory assessments to ensure clear path to regulatory success• Design and implement mechanical, biomechanical, and animal testing and clinical study strategy and initiation for companies with medical devices in various therapeutic areas including orthopedics, spine, oncology• Manage event selection, meeting preparation and Clinical Event Committee meetings• Assist in interaction with the FDA to address all client- and Agency-posed regulatory questions• Prepare meeting presentations and work in close collaboration with internal team and client to prepare for FDA panel meeting• Develop and implement clinical protocols and draft manuscript summarizing retrospective data collection
EDUCATION
Clemson University
Bachelor of Science (BS), Bioengineering and Biomedical Engineering
Clemson University
Master of Science (M.S.), Bioengineering and Biomedical Engineering
SKILLS
ABOUT MARGEAUX ROGERS
Vice President, Regulatory Affairs at MCRA, LLC
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