Experience

Axelgaard Manufacturing Company

• Medical Equipment Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Manager

  • Jul 2021 - Present



BioMedical Life Systems, Inc.

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Manager

  • Dec 2014 - Jun 2021

  Control and maintain all regulatory records including Quality Management System, Training and Device History records. Maintain compliance with ISO and 21CFR 820 standards. Facilitate internal and external audits with notified body and FDA. Manage document control (SOP. CAPA, CR.) Project manager for implementation of FDA UDI program including GS1 upload, GUDID submissions and barcoding. Maintain supplier and vendor records. Control and maintain all regulatory records including Quality Management System, Training and Device History records. Maintain compliance with ISO and 21CFR 820 standards. Facilitate internal and external audits with notified body and FDA. Manage document control (SOP. CAPA, CR.) Project manager for implementation of FDA UDI program including GS1 upload, GUDID submissions and barcoding. Maintain supplier and vendor records.



The ProSource Group, Inc.

• United States
• Staffing and Recruiting
• 1 - 100 Employee

• Administrative Assistant

  • Aug 2011 - Dec 2014

  Download resumes using Gopher ATS. Purchased office supplies and completed expense reports for Sales Director as needed. Download resumes using Gopher ATS. Purchased office supplies and completed expense reports for Sales Director as needed.



AMN Healthcare

• United States
• Staffing and Recruiting
• 700 & Above Employee

• Recruiting Flex Staff

  • Mar 2013 - Jul 2013

  Seasonal position. Assisted recruiters by phone screening applicants for travel nurse positions during implementation of electronic medical records standard. Using ATS, generated reports for potential candidates. Checked candidates for current certifications and required licenses. Seasonal position. Assisted recruiters by phone screening applicants for travel nurse positions during implementation of electronic medical records standard. Using ATS, generated reports for potential candidates. Checked candidates for current certifications and required licenses.



Behr Paint Company

• United States
• Manufacturing
• 700 & Above Employee

• Various positions- see below

  • Sep 1992 - Sep 2003

  Plant Safety Manager, ISO 9001 & Kaizen coordinator-April 2001 - September 2003 Corporate Health and Safety, Workers Compensation Manager April 1996 - April 2001 Mid West Regional Distribution Administrator- March 1995 - March 1996 Purchasing Agent/Buyer -September 1992 - March 1995 Plant Safety Manager, ISO 9001 & Kaizen coordinator-April 2001 - September 2003 Corporate Health and Safety, Workers Compensation Manager April 1996 - April 2001 Mid West Regional Distribution Administrator- March 1995 - March 1996 Purchasing Agent/Buyer -September 1992 - March 1995