Compliance Specialist

2 weeks ago


Minnesota, United States Integrated Resources Full time

At Integrated Resources, we are seeking a highly skilled Compliance Specialist to join our team. As a Compliance Specialist, you will be responsible for reviewing product events from various sources to determine the complaint status and creating the complaint record in the complaint handling system.

This role also involves determining the regulatory reporting status, completing the regulatory report, and ensuring timely submission. Additionally, you will conduct follow-up with internal and external contacts to ensure complete complaint information is obtained and evaluate incoming information for Medical Device Reporting and Vigilance Reporting eligibility.

Key Responsibilities:

  • Review product events to determine complaint status
  • Create complaint records in the complaint handling system
  • Determine regulatory reporting status and complete reports
  • Conduct follow-up with internal and external contacts
  • Evaluate incoming information for Medical Device Reporting and Vigilance Reporting eligibility

Requirements:

  • Bachelor's degree
  • Strong attention to detail
  • Strong analytical skills
  • Strong writing skills
  • Health care professional experience is helpful

Work Environment:

This role requires 40 hours per week, with the need to be onsite 2 days per week - Wednesday and Thursday.



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