Manfred Abel
Regulatory Affairs & Quality Systems
- Role
- Sr Regulatory Affairs Manager Medical Devices, Ivds at Greiner Bio-One Americas
- Location
- Charlotte, NC, US
- LinkedIn followers
- 500 followers
About Manfred Abel
Highly accomplished senior quality systems and regulatory affairs professional with over…
Experience
Sr Regulatory Affairs Manager Medical Devices, Ivds
Jan 2012 — Present · 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
2017 — 2020
University Innsbruck Austria
Master in Science, Microbiology, Biochemistry
Wingate University
Master of Business Administration - MBA, Business Administration and Management, General
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