Find freelancers. Lose those costly delays.

With 1.7 million freelancers, we'll match you with the perfect talent.

or, Register with Elance »

George Gary Calafactor | Elance
 
176985602337900
Last Sign-in: Jun 22, 2013

George Gary Calafactor

Medical Device Consultant
   United States
  |   Narvon, PA

Overview

Minimum Hourly Rate $82

For over 21 years, I have worked for the FDA as a level II certified international medical device investigator and for over 6 years, assisting various US and international medical device, pharmaceutical, and biologic facilities achieve US, European, Canadian, Brazilian, Japanese, and Chinese regulatory compliance. Not only do I have regulatory compliance experience, but also experience in international business as well. I am an ASQ certified (QBA) medical device quality assurance compliance expert. I have performed various hands-on...

Read More »

Skills (5)

Tested
Quality system reconciliations and gap analyses
Preparing and improving quality system written procedures
Quality system auditing and investigating
FDA/EU/Canadian/Brazilian/Chinese regulatory compliance
Quality system training and mentoring

Service Description

George Calafactor is a 27-year food, cosmetic, drug, biologic, clinical, and medical device quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator and over 6 years of industrial experience as a biologic, pharmaceutical, and medical device industry quality assurance consultant, regulatory compliance specialist, and ASQ certified quality biomedical auditor.

George’s educational background includes 2 BS degrees in Chemistry and Metallurgical Engineering from the University of Notre Dame and an MBA in International Business from Indiana University. Currently, George is obtaining online a PhD in International Business from Northcentral University. As such, not only does George have vast internal working knowledge of FDA operations, but he also understands the need to balance industry business goals against external regulations, the linkages between the various quality system and clinical subsystems, and the struggles with quality, cultural, and business barriers to achieve sound quality systems.

George not only has inspected, investigated, and audited all types of US and foreign food, cosmetic, drug, biologic, medical device, and clinical facilities, but has also performed various pharmaceutical and medical device quality assurance and regulatory compliance operations, such as monitoring and maintaining product and quality system failure...

Read More »

Education

Northcentral University
PhD- International Business
-
Indiana University
MBA- International Business
- 1999
University of Notre Dame
BS- Metallurgical Engineering
- 1989
University of Notre Dame
BS- Chemistry
- 1982

Keywords

My Snapshot
Elance Level
Level represents activity and experience on Elance. Freelancers start at Level 1 and achieve higher levels through their work. A higher "Level" indicates greater earnings, ratings and other achievements on Elance. Learn More »
  • 12 months
  • Lifetime
Jobs
0
0
0
Total
Milestones
Hours
Reviews
Recommend
Clients
Total
Repeat
Earnings
Total
Per Client
Identity
Username
georgecalafactor
Type
Individual
Member Since
July 2012
Elance URL
Verifications
0
George Gary Calafactor | Elance

George Gary Calafactor