Position:
Director, Regulatory Affairs at Smith & Nephew, Inc.
Work:
Smith & Nephew, Inc.
since Jul 2007
-
Director, Regulatory Affairs
Smith & Nephew, Inc. Endoscopy Division
Jun 2000 - Jun 2007
-
Manager, Regulatory Affairs
Smith & Nephew, Inc., Endosocpy Division
Apr 1995 - May 2000
-
Regulatory Affairs Specialist
C.R. Bard
Aug 1993 - Apr 1995
-
Regulatory Affairs Associate
CR Bard
Jan 1988 - Jul 1993
-
R&D Project Scientist
Education:
University of Lowell
Bachelor of Science (BSc), Clinical Laboratory Science/Medical Technology/Technologist
Skills:
FDA, ISO 13485, Medical Devices, ISO 14971, CE marking, Regulatory Affairs, Regulatory Submissions, V&V, Quality System, Validation, GMP, Orthopedic, Biotechnology, Commercialization, R&D, Design Controls, Regulatory Due Diligence, Regulatory Policy, MDD, Regulatory Compliance, Promotional Advertising, BRIC Registration Requirements, Sports Medicine Products, Cardiovascular Devices, Design Control, Clinical Research, Product Launch
Honor & Awards:
MT (ASCP) Certified
RAC Certified