Profile

MR Elijah Wreh, MS

Contact Details

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Bio

Accomplished regulatory affairs leader with a proven track record of success in the medical device industry. Comprehensive experience with bringing medical devices to market from viability through design and, verification, validation to global regulatory approvals. Highly proficient at streamlining procedures, implementing best practices, and pulling a talented group of professionals together into a highly performing team.

Education

University of St. Thomas
St. Paul, Minnesota, United States
Master of Science (M.Sc.), 2013
Regulatory Science
2012 To 2013
Dissertation: Premarket Application (PMA) for a Tinnitus Therapy Hearing Systemâ„¢ medical device. The device is a Class III device, which is the FDA most stringent regulatory category for medical devices.
Advisor: Dr. Frank B. Freedman

University of St. Thomas
St. Paul, Minnesota, United States
Post-Baccalaureate, 2012
Medical Device Development
2012 To 2012
Dissertation: None
Advisor: Dr. Frank B. Freedman

St. Cloud State University - College of Science and Engineering
Maple Grove, Minnesota, United States
Master of Science
Regulatory Affairs
2010 To 2011
Advisor: Dr. Charles Swanson

Minnesota State University, Mankato
Mankato, Minnesota, United States
Bachelor of Science, 2009
Human Biology
2007 To 2009
Dissertation: Evaluation of Pretreatment Methods in the Production of Ethanol from Cattail Leaves
Advisor: Mrs. Lois Anderson

Year Entered Profession

  • 2005-2009

Current Organization Type

  • Industry Organization

Job History

Regulatory Affairs Manager (Pre-Market)
Elyria , OH
April 2015 - present

Regulatory Affairs Specialist
Mahwah , NJ
February 2013 - present

Industry Representative, FDA Advisory Committee Neurological Devices Panel
April 2017 - present

Regulatory Affairs Manager
April 2015 - present

Youth Director
NJ
November 2011 - January 2014

President
NJ
November 2012 - February 2013

Regulatory Specialist
February 2012 - December 2012

Medical Device Staff Fellow
July 2011 - September 2011

Research & Development Quality Control Chemist
May 2009 - July 2010

Quality Assurance Technician
January 2007 - May 2009

Caucus goers
January 2007 - January 2008

Quality Control Chemist
September 2003 - December 2006

Highest Degree Earned

  • Masters

Regional Interests

  • Africa
  • Asean
  • Brazil
  • Canada
  • China
  • Europe
  • India
  • Japan
  • Latin America/Carribean
  • Middle East
  • Oceania
  • Other Asia
  • Russia
  • US
  • Worldwide

Product Interests

  • Biologics
  • Biotechnology
  • Combination Products
  • Foods
  • IVDs
  • Medical Devices