SJR Associates is led by Sheila Ramerman, RAC (Devices), founder and Principal Consultant. She has experience in the medical device and diagnostic (IVD) industries in the fields of regulatory
affairs, R&D, clinical studies, and compliance. She has worked with firms ranging from start-up companies who are developing home-testing and near-patient testing devices, to well-established
corporations. However, she puts special emphasis on assisting small and start-up stage companies implement their regulatory, quality, and clinical study functions.
Sheila is well-versed in global regulatory requirements and has prepared submissions and registrations for regulatory agencies around the world. Sheila is currently limiting her consulting to US FDA requirements but continues to keep current with EU and Health Canada requirements. 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 RAC-certified since 1998. Sheila 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 was affiliated with Oregon BioScience Association’s BioPro WorkForce Training program from its inception in 2007 through 2014. She has also been a webcast instructor for Biopractice.com, presenting a medical device regulatory compliance curriculum she designed and developed.