Resumes
Resumes
Regulatory Affairs Manager
View pageLocation:
Miami, FL
Industry:
Medical Devices
Work:
OrbusNeich Medical since Feb 2008
QA Project Leader
Cordis (Biocompatibility) Jun 1993 - Dec 2007
Sr. Scientist
Johnson and Johnson 1993 - 2007
Senior Scientist
QA Project Leader
Cordis (Biocompatibility) Jun 1993 - Dec 2007
Sr. Scientist
Johnson and Johnson 1993 - 2007
Senior Scientist
Education:
Barry University 1994 - 1996
MS, Biomedical Science University of Miami
MS, Biomedical Science University of Miami
Skills:
Iso 13485
V&V
Design Control
Capa
Fda
Medical Devices
Quality System
Gmp
Validation
Change Control
Microbiology
R&D
Iso 14971
Design of Experiments
Quality Assurance
Minitab
Biomedical Engineering
Monoclonal Antibodies
Regulatory Affairs
Biotechnology
Sop
Commercialization
Regulatory Submissions
Glp
Fmea
21 Cfr Part 11
V&V
Design Control
Capa
Fda
Medical Devices
Quality System
Gmp
Validation
Change Control
Microbiology
R&D
Iso 14971
Design of Experiments
Quality Assurance
Minitab
Biomedical Engineering
Monoclonal Antibodies
Regulatory Affairs
Biotechnology
Sop
Commercialization
Regulatory Submissions
Glp
Fmea
21 Cfr Part 11