Associate MDR Vigilance Specialist

4 days ago


Mounds View, Minnesota, United States Integrated Resources, Inc ( IRI ) Full time
Job Title: Associate MDR Vigilance Specialist

Location: Mounds View/Hybrid 2 days Onsite (Wed & Thursday)

Duration: 2 years

Job Summary:

We are seeking a highly skilled Associate MDR Vigilance Specialist to join our team at Integrated Resources, Inc (IRI). As a key member of our regulatory team, you will be responsible for reviewing product events, determining complaint status, and creating complaint records in our complaint handling system.

Key Responsibilities:

  • Review product events from various sources to determine complaint status and create complaint records.
  • Determine regulatory reporting status, complete regulatory reports, and ensure timely submission.
  • Conduct follow-up with internal and external contacts to ensure complete complaint information is obtained.
  • Evaluate incoming information for Medical Device Reporting and Vigilance Reporting eligibility.
  • Monitor the company's drug or medical devices surveillance program, including intake, protocol development, evaluation, processing, and follow-up on adverse reports.
  • Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data, or adverse reaction data as required by regulatory agencies.
  • Review and analyze clinical databases for the extraction of ADE data and integrate the data to ensure the creation of a unified database.
  • Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
  • Deliver and/or manage projects assigned and work with other stakeholders to achieve desired results.

Requirements:

  • Bachelor's Degree
  • Strong attention to detail, strong analytical skills, and strong writing skills


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