Location:
800 west Sandy Lake Rd, Coppell, TX 75019
Work:
Henry Schein Orthodontics
Senior Director Regulatory Affairs
Sybron Dental Specialties Kavokerr A Danaher Corporation
Vice President, Regulatory Affairs
Sybron Dental Specialties
Director, Regulatory Affairs at Sybron Dental Specialties
Education:
University at Buffalo School of Law 1987 - 1990
Doctor of Jurisprudence, Doctorates
Canisius College 1983 - 1987
Bachelors, English, Political Science
Skills:
Fda, Medical Devices, Iso 13485, Design Control, Capa, Regulatory Affairs, Quality System, Cross Functional Team Leadership, Product Launch, R&D, Regulatory Submissions, Gmp, Fda Gmp, Technical Files, V&V, Quality Auditing, Biotechnology, Validation, Iso, Change Control, Regulatory Requirements, 21 Cfr Part 11, Quality Assurance, Root Cause Analysis, Iso 14971, Ce Marking, Commercialization, Medical Device Directive, Sop, Complaint Management, Technology Transfer, Biomedical Engineering, Standard Operating Procedure, U.s. Food and Drug Administration, Iso Standards