Manfred P. Abel
Sr Regulatory Affairs Manager Medical Devices, Ivds @Greiner Bio-One Americas
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WORK HISTORY
Sr Regulatory Affairs Manager Medical Devices, Ivds @Greiner Bio-One Americas
Charlotte, NC, US
Quality Systems, Regulatory Affairs, Registrations and Licensing for FDA and Health Canada, FDA Inspection US and International, FDA 483s responses, Warning letters responses, FDA Presubs, 510k submissions, DMF experience, Recalls, MDR/MPRs, Contracts, Supplier Agreements, Validations, CAPA program, Change control, Document Control, Lead Auditor for 13485, cGMP, 9001, Management Representative.
EDUCATION
California Intercontinental University
Doctor of Business Administration, Doctorate of Business Administration in Healthcare Management & Leadership, DBA
University Innsbruck Austria
Master in Science
Wingate University
MBA
ABOUT MANFRED P. ABEL
Executive Senior Manager for Quality Management and Regulatory Affairs >20 years. FDA,…
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