Ginger Swassing is an accomplished Regulatory Affairs Professional with 35 years of experience in the healthcare industry. Her work experience spans in vitro diagnostic and medical device businesses. Ginger managed the global regulatory strategies and approvals to maximize commercial benefit for all classes of device and diagnostic products. Through her experience in the successful filing/approval of CE Mark devices and diagnostics, Ginger has worked successfully with many different Notified Bodies through contract negotiations, ISO audits and product approvals. She has managed global regulatory organizations and has led the development and remediation of procedures in quality compliance remediation efforts for large multinational manufacturing organizations.
As a consultant since 2015, Ginger has provided guidance to medical device companies in interpretation of the European Union medical device regulations. In this role she developed strategies, procedures and templates to enable the smooth transition from the medical device and in vitro diagnostic directives to the MDR and IVDR.
Prior to the start of her consulting career, Ginger was employed by Abbott Laboratories for 25 years. As Director of Regulatory Affairs for Abbott Vascular and Manager Regulatory Affairs in Abbott’s Diagnostic Division, she was responsible for the full product life cycle regulatory strategies for a broad portfolio of medical devices and IVDs. She established a Regulatory Operations team and managed regulatory subject matter and professional development training. She also held leadership positions in Technical Product Development, and Quality Systems at Abbott.
Ginger earned a Bachelor of Science in Chemistry from the University of Denver, Denver, CO. She has received numerous awards and recognition for her excellence in technical product development, regulatory approval and business efficiencies while employed at Abbott Laboratories. Ginger currently holds the following certifications: RAPS RAC (US and EU).
Saturday, September 21
9:00 AM – 5:00 PM
Sunday, September 22
8:00 AM – 4:00 PM