ABOUT US

SJR Associates is a team of consultants with wide-ranging qualifications and experience. We have experience in the medical device and diagnostic industries in the fields of regulatory affairs, R&D, compliance, and pre-market submissions. Our consultants bring extensive experience from a diverse background in all classes of medical device and diagnostic product development and manufacturing. We have worked with firms ranging from start-up companies who are developing home-testing and near-patient testing devices, to well-established corporations as contract employees. However, we put special emphasis on assisting small and start-up stage companies implement their regulatory, quality, and clinical study functions.

Sheila Ramerman is the founder and Principal Consultant at SJR Associates. She is well-versed in global regulatory requirements and has prepared submissions and registrations for regulatory agencies around the world. Prior to founding SJR Associates, Sheila was responsible for regulatory affairs, quality systems, and/or clinical studies at medical device companies in the San Francisco Bay Area, working with a variety of medical device technologies. Sheila has been a moderator and presenter for medical device seminars and webcasts for the Regulatory Affairs Professional Society, and has been a member of RAPS since 1995. She has been a guest lecturer in the UC-Santa Cruz Regulatory Affairs Certificate Program and for the San Jose State University biomedical engineering department, and has been affiliated with Oregon BioScience Association’s BioPro WorkForce Training program since its inception in 2007. She is currently a webcast instructor for BioPractice.com.