Regulatory Compliance Specialist

1 week ago


Lake Forest, Illinois, United States ICU Medical Full time

Job Overview

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This is a critical role within the Global Complaint Management (GCM) organization, requiring strong expertise in managing FDA Medical Device Reporting (MDR) and EU Medical Device Incident Reporting (MIR) case information.

The ideal candidate will possess a deep understanding of medical terminology, regulations, and industry standards. Strong analytical skills, attention to detail, and effective communication are essential for success in this position.

Responsibilities

  • Serve as a subject matter expert for MDR/MIR regulatory reporting within GCM.
  • Maintain case tracker and Device Safety Mailbox with triage and forward of reports as received each day.
  • Track and ensure on-time regulatory submissions.
  • Respond to Regulatory Agency inquiries and manage timeliness of inquiries to ensure on-time responses.
  • Maintain pertinent communication with vendors performing MDR/MIR case processing.
  • QC cases in Safety Database upon appearance in ICU Medical workflow.
  • Complete periodic/aggregate MDR/MIR reports as assigned.
  • Assist with new employee training and continuing education.
  • Maintain working knowledge of complaint processing to serve in backup capacity.
  • Provide support for audits and work on special projects as needed.
  • May serve as operations team leader in the absence of the team manager.

Requirements

  • Experience with or knowledge of medical terminology and how drug products and medical devices are used in a clinical setting.
  • Intermediate experience with computers and software such as Outlook, Word, Excel, PowerPoint, WebEx, TrackWise, Agile.
  • Must be able to communicate effectively with internal and external customers.
  • Demonstrate critical thinking and problem-solving skills.
  • Proficiency in complaint data analysis and presenting a summary to management.

Education and Experience

  • Minimum 4 years of experience in a healthcare environment, and/or within a quality/compliance/regulatory organization in an FDA-regulated business.
  • Minimum 4 years of MDR or MIR Regulatory Report Submissions.

Salary Range

$80,000 - $120,000 per annum, depending on location and experience.

About ICU Medical

ICU Medical is an Affirmative Action and Equal Opportunity Employer, committed to diversity and inclusion.



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