With 15 years of direct experience in medical devices and regulatory affairs, Sarah Pleaugh is a Director (Subject Matter Expert) of Regulatory Affairs at MCRA. At MCRA, Ms. Pleaugh focuses on orthopedic and spine devices, with a specialty in U.S. regulatory strategies and submissions to FDA, including pre-submissions, 510(k)’s, investigational device exemption (IDE) applications, and premarket approval (PMA) applications. Ms. Pleaugh also provides consulting support on drafting and reviewing clinical study reports, preparing and attending FDA meetings, responding to FDA deficiencies, and analyzing literature in support of pre-clinical and clinical strategies.
Ms. Pleaugh holds a Bachelor of Science in Biomedical Engineering from Michigan Technological University. While earning her degree, Ms. Pleaugh spent her summers interning at a medical device engineering testing laboratory gaining valuable expertise and technical writing skills.
Prior to joining MCRA in November 2021, Ms. Pleaugh worked in industry at both small and large medical device companies in regulatory affairs and engineering roles. Ms. Pleaugh also has vast experience in supporting international registrations, quality system inspections, labeling and advertising/promotional review, risk management, and both new product development and remediation programs.
Overview
Ms. Pleaugh is a biomedical engineer and seasoned regulatory professional with a clear understanding and strategic view of the U.S. FDA regulatory requirements for Class I, II and III medical devices. She has extensive experience in non-clinical and clinical data strategies, technical writing, and authoring a wide range of submission types to meet FDA’s requirements. Ms. Pleaugh prides herself on having effective communication, writing, and organization skills to best support MCRA’s clientele.
At MCRA, Ms. Pleaugh is responsible for managing and supporting MCRA’s clientele in developing and authoring regulatory strategies and submissions, communicating with the FDA, and leading projects through the FDA regulatory process. Ms. Pleaugh works collaboratively with clientele and other MCRA departments, such as clinical, biostatistics or reimbursement, to guide timely progress and development of regulatory projects.