Lauren P Nitahara

Lauren Nitahara

Senior Regulatory Affairs Specialist

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Location:

186 Jonathan Pl, Somerset, NJ 08873

Industry:

Medical Devices

Work:

ConvaTec - Skillman, NJ since Jan 2012
Regulatory Affairs Specialist
Integra LifeSciences Feb 2010 - Dec 2011
Regulatory Affairs Specialist, Latin America
META Solutions, Inc. May 2007 - Jan 2010
Regulatory Consultant
Hitachi Ltd. May 2006 - Aug 2006
Pharmaceutical IT Summer Intern
Johnson & Johnson PRD May 2005 - Aug 2005
Pharmaceutical Project and Technology Business Support Summer Intern

Education:

Hobart and William Smith Colleges 2004 - 2008
BA, Asian Studies, Studio Art Ridge High School 2000 - 2004
HS Diploma

Skills:

Regulatory Affairs
Fda
Medical Devices
Regulatory Submissions
Design Control
Quality System
Software Documentation
Ce Marking
Adobe Acrobat
Computer System Validation
Iso 13485
Capa
Product Launch
Fda Gmp
Regulatory Filings
21 Cfr
Cardiology
Regulatory Documentation
Biocompatibility
Post Market Surveillance
Validation
Pharmaceutical Industry
U.s. Food and Drug Administration
Technical Files
Iso 14971
Creative Problem Solving
Sterilization
Regulatory Strategy Development
International Regulations
Quality System Compliance
Anvisa
Cultural Awareness
Problem Solving
Corrective and Preventive Action
Organizing
Adverse Event Reporting
Attention To Detail
Heath Canada

Certifications:

Notary, Middlesex County, New Jersey

Lauren Nitahara

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