Megan Mekoli
Sr Regulatory Affairs Specialist - Clinical @Medtronic
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WORK HISTORY
Sr Regulatory Affairs Specialist - Clinical @Medtronic
Providing regulatory support for clinical studies of class I, II, and diabetes medical devices.
EDUCATION
Iowa State University
Doctor of Philosophy (Ph.D.), Analytical Chemistry
University of Minnesota Morris
Bachelor of Arts (BA), Chemistry with subfield: Biochemistry
SKILLS
ABOUT MEGAN MEKOLI
Experienced senior regulatory affairs specialist at Medtronic. Extensive knowledge of FDA regulatory policies, product review processes, and Food and Drug law. Clear scientific communication and excellent technical writing skills. Organized leader and skilled multi-tasker.Specialties and Interests• Public health• Regulatory affairs• Leadership and workflow optimization• Data science: pivot tables, data visualization, multivariate statistical analysis (e.g, ANOVA, PCA)• Tobacco science and tobacco regulation: Tobacco Control Act of 2009, regulatory process, document flow, tobacco chemistry, laboratory accreditation, method validation• Technical writing• Scientific communication• Chemical instrumentation and analytical methodology• Elemental analysis and inductively coupled plasma-mass spectrometry (ICP-MS)
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