Manfred Abel

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.

California Intercontinental University

Doctor of Business Administration, Doctorate of Business Administration in Healthcare Management

University Innsbruck Austria

Master in Science, Microbiology, Biochemistry

Wingate University

Master of Business Administration - MBA, Business Administration and Management, General