Profile

Ginger Cantor, RAC

Contact Details

Bio

Experience • Regulatory Affairs/Quality professional (pharmaceuticals, medical devices, and biological products) with >20 years experience. Areas of expertise include regulatory strategy and Agency/Notified Body interactions, global submissions, risk assessment and mitigation, auditing, contract outsourcing, quality systems, validation (facility, systems, product, process and software), adverse event/medical device reporting, and pre-clinical (GLP) studies. • Product experience includes biologics/bio-pharmaceuticals, implantable devices, conventional dose and transdermal pharmaceutical products, hand sanitizers, manual and electronic stethoscopes, combination products, medical tapes, electrosurgical accessories, ECG monitors, ECG cables and leads, X-ray CT scanners, intra-oral dental scanners, medical imaging software, PACS and MDDS systems, dental restorative products, and surgical masks. • Certified Regulatory Affairs Professional (RAC); member of the Regulatory Affairs Professionals Society (RAPS). • MBA with major concentration in Finance, minor concentration in Operations Management. • Direct supervisory experience.

Education

University of Minnesota - Carlson School of Management
MBA
1999 To 2001

San Jose State University
1986 To 1990

Virginia Polytechnic Institute and State University
BS
1981 To 1984

Year Entered Profession

  • 1990-1994

Job History

Principal Consultant
March 2015 - present

Senior Regulatory Affairs Specialist
June 2013 - February 2015

Regulatory Affairs Advanced Specialist
November 2008 - May 2013

Director of Regulatory Compliance
September 2006 - November 2008

Regulatory Affairs Specialist
February 2004 - August 2006

Senior Regulatory Affairs Associate
May 2001 - January 2004

Regulatory Affairs and Quality Manager
October 1996 - June 1999

Quality Assurance Manager
February 1993 - February 1996

Quality Assurance Manager
January 1992 - January 1993

Highest Degree Earned

  • Masters

Regional Interests

  • US
  • Worldwide

Product Interests

  • Biologics
  • Combination Products
  • Generic Drugs
  • Innovative Pharmaceuticals
  • Medical Devices
  • OTC drugs