Experience

Medtronic

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• MDR / Vigilance Specialist

  • Aug 2008 - Present

• Sr MDR / Vigilance Specialist

  • Aug 2008 - Present

• Senior Customer Quality Compliance Specialist

  • Aug 2008 - Present



Medtronic Navigation, Inc.

• 1 - 100 Employee

• Regulatory & Quality Specialist

  • 2008 - Present

  Extensive knowledge of Regulatory Affairs and Quality Assurance associated with Medical Devices. Including: Code of Federal Regulations Title 21 Part 803; FDA 45-day Responses, Medical Device Reports (both 30-day and 5-day MDRs); FDA, TUV, and Internal Audits; Complaint and CAPA systems. Extensive knowledge of Regulatory Affairs and Quality Assurance associated with Medical Devices. Including: Code of Federal Regulations Title 21 Part 803; FDA 45-day Responses, Medical Device Reports (both 30-day and 5-day MDRs); FDA, TUV, and Internal Audits; Complaint and CAPA systems.