Resumes
Resumes
Location:
Rochester, NY
Industry:
Medical Devices
Work:
Ortho Clinical Diagnostics
Senior Regulatory Affairs Associate
Carestream Health Feb 2012 - Aug 2014
Regulatory Affairs Manager
Angiotech Jun 2008 - Dec 2011
Regulatory Affairs Specialist
Angiotech 2003 - 2008
Research Associate
Sts Biopolymers 1998 - 2003
Formulation Scientist
Senior Regulatory Affairs Associate
Carestream Health Feb 2012 - Aug 2014
Regulatory Affairs Manager
Angiotech Jun 2008 - Dec 2011
Regulatory Affairs Specialist
Angiotech 2003 - 2008
Research Associate
Sts Biopolymers 1998 - 2003
Formulation Scientist
Education:
State University of New York College at Brockport 1986 - 1991
Bachelors, Bachelor of Science, Biology, Chemistry
Bachelors, Bachelor of Science, Biology, Chemistry
Skills:
Regulatory Affairs
Medical Devices
Design Control
R&D
Risk Analysis
510 K
Polymers
Coatings
Formulation Development
Product Development
Iso 13485
Iso 14971
Drug Delivery
Ce Marking
Mdd
Regulatory Submissions
Combination Products
Iso
Cgmp
Gmp
Fda
Capa
V&V
Medical Device Directive
21 Cfr Part 11
Formulation
Gxp
Regulatory Requirements
Quality Control
Quality System
Medical Devices
Design Control
R&D
Risk Analysis
510 K
Polymers
Coatings
Formulation Development
Product Development
Iso 13485
Iso 14971
Drug Delivery
Ce Marking
Mdd
Regulatory Submissions
Combination Products
Iso
Cgmp
Gmp
Fda
Capa
V&V
Medical Device Directive
21 Cfr Part 11
Formulation
Gxp
Regulatory Requirements
Quality Control
Quality System
Certifications:
Rac~ Regulatory Affairs Certification (Us)
Regulatory Affairs Professionals Society (Raps)
Regulatory Affairs Professionals Society (Raps)