Lake Forest, Illinois
Regulatory Reporting Analyst Job Opening in Lake Forest, Illinois - Born in the 1980's we are recognized as a lead medical device company. We design and create some of the world?s safest, reliable medical devices and systems for infusion therapy. Our diverse product line includes; needle free vascular access devices, custom infusion sets, closed system hazardous drug handling devices and systems, advanced sensor catheters, etc.
What you'd be doing?
The Analyst, Device Safety and Regulatory Reporting (DSRR) manages reportable device complaints for the global Devices Medical organization.
You will gather customer contact and gathering of pertinent details of reportable events.
Escalate high severity events and cases to Management.
Create regulatory reports for submission to FDA or Regional Competent Authority.
Own and manages the event through life cycle from assessment of reportability through regulatory reporting, product investigation, and review for closure/reopening as needed.
Propose solutions to day-to-day processing issues and enhancement opportunities
What you need for this opportunity?
Bachelor?s degree in related field is required
RN or PA licensure preferred
1-2 years of experience in healthcare environment within nursing or Bio-medical engineering environment or 1-2 years in organization in FDA regulated business
Job Type: Full-time
Salary: $75,000.00 /year
Required education:
Bachelor's
Required experience:
Regulatory Compliance: 2 years
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