Sheila Ramerman

Sheila Ramerman, RAC, is the founder and Principal Consultant at SJR Associates, a medical device regulatory affairs and quality systems consulting firm. SJR Associates has particular expertise with near-patient testing technologies and with assisting start-up stage companies implement their regulatory, quality, and clinical studies functions. Prior to founding SJR Associates, Ms. Ramerman was responsible for regulatory affairs, quality systems, and/or clinical studies at medical device companies in the San Francisco Bay Area. She has hands-on experience with devices in neurology, clinical laboratory, rehabilitation, orthopedics, and general hospital disciplines. She works with a wide range of medical device companies, from start-ups to multi-national corporations. She has successfully submitted over 40 510(k) submissions, and was instrumental in achieving PMA approval for a novel radiology software product. She has also been instrumental in recent de novo submissions for clients, two of which have been granted. Ms. Ramerman has been RAC certified since 1998.

Prior to her experience in the medical device industry, Ms. Ramerman was a Clinical Laboratory Scientist at community hospital laboratories in Washington State. She holds an AA in Medical Laboratory Technology from Shoreline Community College in Seattle, WA and a BA in Healthcare Administration from St. Mary’s College in Moraga, CA.

Participating years: 2018, 2019