Amanda B. is a highly experienced regulatory affairs professional with a strong background in managing regulatory strategies for over 20 projects at Getinge, where Amanda has held various positions since 2018, including Principal Regulatory Affairs Specialist. Responsibilities include preparing worldwide registrations, authoring FDA non-filing justifications, supporting field correction activities, and conducting third-party audits. Prior to Getinge, Amanda worked at Magellan Diagnostics, Inc. as a Regulatory Affairs Specialist, QA Engineer, and QC Analyst, contributing to quality processes for IVD instruments and overseeing audits and submissions. Amanda also has experience as a Lab Scientist at Layne Christensen and as a Pharmacy Technician at CVS Pharmacy. Academic qualifications include a Master's degree in Regulatory Affairs from Northeastern University and a Bachelor's degree in Pharmaceutical Sciences from Massachusetts College of Pharmacy and Health Sciences.
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