Associate MDR/Vigilance Specialist Job at Medtronic, Minnesota

  • Medtronic
  • Minnesota

Job Description

Associate MDR/Vigilance Specialist role focused on intake, documentation, and investigation of medical device complaints for Endoscopy products. Responsibilities include regulatory reporting to FDA and other bodies, complaint assessment, and escalation of complex issues in accordance with applicable regulations.

Responsibilities

  • Receive, assess, and document product complaints in Global Complaint Handling system
  • Evaluate events for Medical Device Reporting and Vigilance reporting eligibility
  • Initiate and complete regulatory submissions to FDA and international regulatory bodies
  • Conduct investigations to determine cause, device relationship, and need for formal review
  • Contact field personnel, healthcare providers, and patients to gather missing complaint information

Requirements

  • Bachelor's degree in any field
  • High proficiency with Microsoft Office, SAP, Siebel, or Oracle Clinical
  • Knowledge of 21 CFR Sections 803 and 820 regulations
  • Strong attention to detail and analytical skills
  • Excellent written and oral communication abilities
  • Unrestricted U.S. work authorization required at hire

Job Tags

Work at office

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