RAPS Company
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RAPS Employees
RAPS April 2012 - November 2013
Sears Canada November 2010 - November 2012
Skills
Merchandising, Time Management, Inventory Management, Store Management, Customer Service, Security, Crowd Control, Scheduling, Profit, Management
Education
Lakeland College Canada 1995 — 1996
Year One, Rehabilitation Practicitioner
Harry Ainlay High School 1991 — 1994
High School Diploma
Protégé Biomedical June 2013 - Present
3M August 2010 - June 2013
Zimmer Spine 2007 - August 2010
RAPS 2006 - 2010
Lifecore Biomedical May 2006 - November 2007
Skills
Regulatory Affairs, FDA, Medical Devices, Orthopedic, ISO 13485, Design Control, CAPA, Regulations, V&V, Quality System, ISO 14971, GMP, CE marking, Validation, Regulatory Submissions, Sop, Biomedical Engineering, 21 CFR Part 11, Product Launch, Process Improvement
Education
University of Saint Thomas - School of Business 2008 — 2011
MBA
Minnesota State University, Moorhead 2003 — 2007
BS & BA, International Business, Spanish
Universidad Nacional - Costa Rica 2005 — 2006
International Business
George Washington University May 2015 - Present
Amarex Clinical Research, LLC July 2014 - Present
Amarex BioVentures January 2012 - Present
Montgomery College February 2011 - Present
GAIBP 2006 - Present
American University 2005 - Present
Amarex Clinical Research 2006 - 2014
RAPS 2006 - December 2013
Technical Resources International, Inc. 2004 - 2006
National Institutes of Health October 2003 - July 2004
Skills
Training, Technology Transfer, Clinical Trials, Biotechnology, FDA, Product Development, Clinical Development, Regulatory Affairs, Drug Development, GCP, Pharmaceutical Industry, Quality Assurance, Lifesciences, Clinical Research, Medical Devices, Life Sciences, Oncology, Molecular Biology
Education
Delhi University 1993 — 1997
Ph.D., Biochemistry
National Dairy Research Institute 1990 — 1993
MS, Biochemistry
Philips Healthcare September 2014 - Present
RAPS 2015 - 2015
RAPS 2015 - 2015
Dot Decimal October 2006 - September 2014
Genesis School January 2004 - September 2006
Skills
FDA, Validation, Medical Devices, ISO 13485, Regulatory Affairs, Pharmaceutical Industry, Quality System, Design Control, Process Improvement, Sop, 21 CFR Part 11, V&V, Regulatory Submissions, ISO 14971, Regulatory Requirements
Education
San Diego State University-California State University 2009 — 2011
MS, Regulatory Affairs
University of North Florida 2000 — 2003
BA, Art History
Hamann QR Consulting February 2014 - Present
RAPS January 2011 - Present
Beckman Coulter March 2012 - February 2014
PerkinElmer June 2010 - March 2012
Levitronix 2008 - 2010
Spine Implant Company 2008 - 2008
GE Healthcare 2005 - 2008
AACC 2003 - 2006
Boston Scientific 2004 - 2005
Dome Imaging 2002 - 2004
Skills
CAPA, 510 K, Regulatory Affairs, Design Control, Quality Systems, Risk Analysis, Quality System, Medical Devices, ISO 13485, FDA, GMP, ISO 14971, Validation, Regulatory Submissions, V&V, Biotechnology, Technology Transfer, Quality Assurance, PMA, Clinical Trials, Biomedical Engineering, Sop, CE marking, Lifesciences, Regulatory Requirements, R&D, 21 CFR Part 11, 21 CFR, Change Control, GLP, Clinical Development, GCP, GxP, Biopharmaceuticals, Quality Auditing, Commercialization, IND, FDA GMP, Quality Management, Medical Device Directive, Cross-functional Team..., IVD, ISO
Education
Rochester Institute of Technology 1984 — 1988
MS, Clinical Chemistry
State University of New York College at Cortland
BS, Biology Minor in Chemistry
Orasi Consulting June 2006 - Present
RAPS 2010 - 2012
Haag-Streit May 2006 - February 2008
Haag-Streit 2006 - 2008
Research Associates September 2003 - April 2006
NEEC June 1996 - September 2003
American Community Schools of Athens Greece 1992 - 1996
Skills
Quality System, FDA, Clinical Trials, Medical Devices, Clinical Research, Regulatory Submissions, Regulatory Affairs, Ophthalmology
Education
Adelphi University 1993 — 1994
Teaching, Education and Mathematics
Stony Brook University 1979 — 1984
BEME, Engineering
DSM Biomedical October 2011 - September 2015
Orthopedica Surgical Manufacturers Association October 2011 - September 2015
OSMA 2011 - September 2015
RAPS 2010 - July 2012
Kensey Nash Corporation February 2009 - October 2011
ORTHOVITA INC January 2006 - February 2009
Orthovita August 2004 - January 2006
WYETH-AYERST LABORATORIES January 1987 - March 1990
Skills
510 K, IDE, Medical Devices, ISO 13485, Pharmaceuticals, FDA, CE marking, Documentation, Auditing, SOP, Regulatory Submissions, Quality System, Sop, Biotechnology, Regulatory Affairs, Software Documentation, Design Control
Education
Rutgers University-New Brunswick
BS, Medical Technology
Villanova University
MS, Biology
Victor12 July 2014 - Present
CSC September 2013 - Present
Freelance Instructional Designer 2008 - 2014
CSC February 2012 - September 2013
CSC February 2006 - January 2012
Datatrac Information Services 2004 - 2005
RAPS 2003 - 2004
Aether Systems, Inc 1999 - 2001
State Farm Insurance Company 1997 - 1999
Professional Educator 1988 - 1998
Skills
Program Management, Training, Project Management, Change Management, Software Documentation, Technical Writing, PMP, Microsoft Office, Instructional Design, Editing, Leadership, Government, Outsourcing, Management, Vendor Management, ITIL, IT Service Management, Team Building, Security Clearance, Proposal Writing, Team Leadership, Integration, IT Strategy, E-Learning, Quality Assurance, Instructor-led Training, Employee Training, Visio, Needs Analysis, PMO, Technical Training, IT Management, Service Delivery, Troubleshooting, Call Centers, Business Process, Knowledge Management, ADDIE, IT Operations, Captivate, Blended Learning, Training Delivery, RFP, Technical Support
Education
Cornell University 2010 — 2011
Online Certificate, Change Leadership
University of Virginia 1996 — 2000
Master's degree, Instructional Technology
Assumption College 1984 — 1998
Bachelor's degree, Education & Psychology
Mount Saint Charles Academy 1978 — 1984
High School, College Preparatory
Association for Financial Professionals 2012 - Present
Association for Financial Professionals September 2004 - November 2012
RAPS September 1999 - July 2004
GE Capital IT Solutions December 1987 - August 1999
Skills
Newsletters, Graphics, Publications, B2B, Marketing Communications, Photography, Press Releases, Copywriting, Marketing, Advertising
Education
University of Maryland College Park 1976 — 1979
BS, Advertising Design
Lynchburg College 1974 — 1976
The Jewish Federation of Greater Washington June 2010 - Present
r-circled September 2001 - Present
Taproot Foundation March 2010 - January 2011
The Chronicle of Higher Education & The Chronicle of Philanthropy December 2005 - June 2010
RAPS October 2004 - December 2005
Westat August 2002 - October 2004
Levine & Associates April 1996 - April 2002
Skills
InDesign, Graphic Design, Invitations, Illustrator, Web Design, Graphics, Adobe Acrobat, Photoshop, Editorial, QuarkXPress, Mac, Typography, Corporate Identity, Adobe Creative Suite, Art Direction
Education
Thomas J. Piwowar & Associates (TJP&A)
Interactive Media Design & Web Design Pro courses (Certificate)
Thomas J. Piwowar & Associates (TJP&A)
Effective Email Promotion Workshop
Thomas J. Piwowar & Associates (TJP&A)
Effective Email Promotion Workshop
Thomas J. Piwowar & Associates (TJP&A)
Create a Web Page Workshop
School of Visual Arts 1990 — 1992
Bachelor of Fine Arts, Graphic Design, Editorial Design
Rochester Institute of Technology 1988 — 1990
Associates, Graphic Design
Music and Art (Fiorello H Laguardia) 1984 — 1988
Design and Photography
ISPE May 2015 - Present
YPO - Young Presidents' Organization May 2012 - May 2015
AdvaMed August 2010 - May 2012
NAHB October 2007 - August 2010
RAPS July 2005 - October 2007
DMAW June 2002 - June 2004
Skills
Team Building, Strategic Planning, Budgeting, Program Development, Volunteer Management, Staff Development, Program Management, Problem Solving, New Business Development, Non-profits, Association Management, Board Relations, Policy, Growing Revenue, Expense Reduction, Budgets, Marketing, Media Relations, Fundraising, Nonprofits, Strategic Communications, Public Relations, Management, Leadership, Strategy, Leadership Development, Event Management, Proposal Writing, Process Improvement, Organizational..., Training, Public Speaking, Community Outreach, Event Planning, Public Policy, Marketing Communications, Government, Expenses, Project Management, Business Development, Social Media, Management Consulting, Membership Relations
Education
University of Maryland University College 2010 — 2012
Master of Business Administration (M.B.A.)
University of Maryland University College 2007 — 2010
Master's Degree, Association Management
Cambridge Rindge and Latin School 1990 — 1992
Tabor Academy 1988 — 1990
RAPS February 2004 - Present
The Curtis Group, LLC January 2003 - Present
Bridgemedica June 2010 - January 2014
the curtis group,llc 2003 - 2010
MediSpectra 2006 - 2007
Cardiofocus 2001 - 2002
Boston Scientific Corporation 1993 - 2001
St. Jude Medical February 1991 - May 1993
C.R. Bard 1987 - 1991
meadox medicals 1985 - 1987
Skills
Medical Devices, Design Control, FDA, CAPA, ISO 14971, ISO 13485, V&V, Quality System, Regulatory Affairs, Biomedical Engineering, Regulatory Submissions, Validation, PMA, Quality Auditing, GMP, Quality Assurance, 21 CFR, Catheters, Product Launch, 21 CFR Part 11, Change Control, Design of Experiments, R&D, Regulatory Requirements, CE marking, Commercialization, GLP, Biopharmaceuticals, Medical Device Directive, Technology Transfer
Education
Quinnipiac University
Radiologic Technology/Science - Radiographer
Isologic Innovative Radiopharmaceuticals Inc March 2014 - Present
Cardinal Health August 2011 - March 2014
GE Healthcare Canada June 2005 - August 2011
National Physical Laboratory January 2002 - December 2004
Bhabha Atomic Research Centre 1987 - 1991
RAPS 1984 - 1987
Skills
GMP, CAPA, APQR, PROCESS IMPROVEMENT, CHANGE CONTROL, DOCUMENT CONTROL, VALIDATION, GMP TRAINING, 5S, GMP AUDITS, COMPLIANCE, QUALITY ASSURANCE, HEALTH CANADA, DOCUMENTATION, DEVIATION REPORTS, MEDICAL DEVICE..., Post Market Surveillance
Education
UNIVERSITY OF BOMBAY 1988 — 1989
M.Sc, Physical Chemistry
University of Madras 1981 — 1984
BSc, Chemistry
RAPS August 2011 - Present
North Area Officials Association June 2008 - Present
RAPS August 1992 - June 2011
Skills
Public Speaking, Staff Development, Curriculum Development, Leadership Development, Educational Leadership, Educational Technology, Classroom, Program Development, Curriculum Design, Higher Education, Registered Official
Education
Central Michigan University 1990 — 1992
Master's Degree in Education, Educational Leadership and Administration, General
Central Michigan University 1978 — 1982
Bachelor's degree, Education