Jessica Schafersman
Subject Matter Expert, Design Controls
Jessica Schafersman is a Biomedical Engineer, Project Management Professional, and Certified Usability Analyst, with more than 20 years of experience in medical product development, combination products, sterile implants, sterile disposables, capital equipment and instrumentation spanning Class I, II, and III device classifications.
As a Subject Matter Expert at Regulatory Compliance Associates® (RCA) she is responsible for helping clients create and improve design files for their products, and sometimes their entire Quality Management System. She also participates in company advocacy efforts with federal agencies, congressional personnel, and public health groups.
Jessica started her career in a medical device startup, working directly with physicians and end users to develop a bleeding edge surgery system. Since then, her work experience has spanned combination products, sterile implants, sterile disposables, capital equipment, software, and instrumentation at all phases of development. She has worked within companies both big and small so she can appreciate the challenges and opportunities that each affords. She joined RCA as a full-time consultant in 2014.
Jessica got her Bachelor of Science in Biomedical Engineering as well as her Certificate of Business Administration at Saint Louis University in Saint Louis, MO.
Jessica’s Certifications
- Project Management Professional (PMP) | (February 2014)
- Certified Usability Analyst (CUA) | (December 2016)
Special Training
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