Sheila J. Ramerman, RAC – Principal

Ms. Ramerman has 20 years of experience in product development, regulatory affairs, clinical trial development and execution, and quality assurance for a wide range of in vitro diagnostics (IVD) and medical devices. Combined with over 14 years of experience as a medical laboratory technologist, she has an in-depth understanding of software-controlled and electronic devices. Ms. Ramerman developed and executed regulatory strategies and participated in defining business strategies for a variety of medical device manufacturers including Biocircuits Corporation, ORATEC Interventions, Natus Medical, and Apieron Biosystems and has supported three employers in successful IPO activities. She has filed over 30 510(k)s, several pre-IDE applications, and one PMA. Ms. Ramerman has prepared European regulatory documentation, including writing technical files and has coordinated registrations for a variety of medical devices worldwide (Pacific Rim, South America, Canada, non-EU European countries). She has developed and managed quality systems compliant with FDA QSR and ISO requirements. Prior to beginning her consulting career, Ms. Ramerman was the Director of Regulatory Affairs/Quality Assurance at Natus Medical, Inc., Director of RA/Clinical Affairs for ORATEC Interventions, and Director RA/QA for Biocircuits Corporation. She is an active member of the Oregon Biotechnology Association (OBA) and provides WorkForce Training on behalf of OBA. Ms. Ramerman received her Bachelor of Arts in Health Services Administration from Saint Mary’s College in Moraga, California and her AA in Medical Laboratory Technology from Shoreline Community College in Shoreline, Washington. She was certified by the Regulatory Affairs Professional Society in 1995.

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