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Regulatory Post Market Surveillance Analyst
hace 2 meses
Job Summary
The Regulatory Post Market Surveillance Analyst plays a critical role in ensuring the quality and safety of medical devices. As a key member of the quality team, this position is responsible for investigating customer complaints, making initial reporting decisions, and ensuring the completeness and consistency of complaint documentation.
Key Responsibilities:
- Investigate customer complaints daily, performing preliminary classification and escalating complaints that require additional review.
- Conduct Failure Analysis investigation reviews and escalate complaints that require additional review.
- File Malfunction MDR Reports as identified and escalate Adverse Event or Incident reports to Level IV Analysts as necessary.
- Evaluate documentation for completeness and consistency, assigning additional actions as needed to close the complaint file.
- Approve final complaint files for closure after all applicable actions are completed.
- Manage complaint workload to required backlog goals and review and analyze lot documentation (DHRs) to determine if there are any anomalies related to reported product failures.
- Escalate complaints to the Regulatory Post Market Surveillance Manager or Lead when new failure modes are encountered.
- Evaluate complaints for reporting requirements in accordance with company procedures and Regulatory requirements.
- Interface with Customer Service and hospitals to gather additional information required for complaint investigation, including retrieval of RMA.
- Create customer response letters upon request and provide peer review and feedback of complaints and reports.
- Participate in new hire training and continuous Regulatory Compliance training as required and participate in process improvement activities to continuously improve process effectiveness.
- Execute on projects as required and perform other duties as directed.
Requirements:
- Organizational skills and ability to manage multiple priorities.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Ability to work in a fast-paced environment and meet deadlines.
- Proficiency in Microsoft Office and ability to learn new software applications.
Company Overview:
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