As a complaint consultant you will support the complaint investigation process and execution for product design and process related complaints for Post-Market Medical Device and Combination Products.
Responsibilities:
- Conducts post-market surveillance activities including complaint/MDR handling
- Will ensure complaint containment reports are run as required procedures, and coordinate activities to resolve issues that appear on the reports.
- Ensure complaint meets department requirements.
- Perform appropriate evaluation steps to ensure all available information is present so that team can determine reportability.
- When necessary, perform remediation activities on complaint files to bring them up to standard.
- Will need to be able to evaluate complaint files that have been identified as being filed late with the reporting agency for an Adverse Event.
- Review intake source systems, complaint handling databases, and other systems to determine chain of events in the complaint process.
- Coordinate the report assignments to ensure activities are completed in a timely manner and escalate issues to the appropriate department for resolution if required
- Responsible for completing work activities, as defined by the project lead, on schedule and in accordance with the allotted hours
- Communicates project risk and issues to the project lead in a timely fashion
Requirements:
- Minimum of 2 years of experience in Medical Device Complaint Handling
- ·Medical device engineering experience
- Knowledge and understanding of end-to-end device complaint handling process including Adverse Event Reporting to US FDA (MDR) and OUS Regulators
- Experience completing device complaint investigations and reportability determinations
- Excellent written and verbal communication
- Ability to manage multiple cases in parallel to ensure timely completion of activities
- Understands and complies with all current cGMP and QSR requirements as defined by management our/or outlined in standard operating procedures as well as recording necessary documentation to comply with various regulatory agencies
- Experience with Combination products is a plus
- Experience working Trackwise and Argus is a plus
- Able to clearly explain and present technical information within and outside of the organization (i.e. technical resource to 3rd Party vendors, medical personnel, marketing, service publications, training, R&D, etc.)
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