Biography

Sheila Ramerman brings extensive experience from a diverse background in all classes of medical device development and manufacturing. She is well-versed in global regulatory requirements and has prepared submissions for regulatory agencies around the world. Her focus on small and start-up companies means that she understands the need for efficient and pragmatic approaches to regulatory and quality issues. With over 16 years’ experience in the medical device industry, coupled with 14 years’ experience as a healthcare practitioner, Sheila’s accomplishments and professional affiliations include:

Certifications:

		Regulatory Affairs Certified (RAC), Regulatory Affairs Professional Society
		Clinical Laboratory Scientist (CLS), National Certification Agency for Medical Lab. Personnel
		Medical Laboratory Technician (MLT), American Society for Clinical Pathology

Memberships:

		Regulatory Professional Society (RAPS)
		American Society for Clinical Chemistry (AACC)
		American Society for Clinical Laboratory Science (ASCLS)

Professional Activities:

		Speaker/Organizer, RAPS Medical Device Overview webcast, June 2006
		Moderator and Speaker, RAPS 510(k) webcast, November 2003.
		Moderator and Speaker, RAPS 510(k) Workshop, San Francisco, CA, 2003.
		Program Committee Member, RAPS Medical Device Seminar, San Francisco, CA, 2003.
		Speaker, RAPS 510(k) Workshop, San Francisco, CA, 2002.
		Guest lecturer on medical device regulation, Biomaterials Engineering course, San Jose State University, 1999 – 2001.

Education:
 

		BA, Health Services Administration, Saint Mary’s College, Moraga, CA, 1993.
		Associate of Applied Arts and Sciences, Clinical Laboratory Technology, Shoreline Community College, Seattle, WA, 1975.