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Description:

JOB TITLE: Regulatory Post Market Surveillance Specialist

Department: Post Market Surveillance

Reports to: Manager, Regulatory Post Market Surveillance


Primary Function of Position:

The Regulatory Post Market Surveillance Specialist investigates customer complaints, makes an initial reporting decision, provides failure analysis letters, and ensures completeness and consistency of complaint and related documentation.

Roles and Responsibilities:

This position has responsibility and authority for:
Investigating complaints daily:
o Perform the preliminary classification of complaints and escalate complaints that require additional review.
o Perform Failure Analysis investigation review and escalate complaints that require additional review.
o File Malfunction MDR Reports as identified
o Escalate Adverse Event or Incident reports to Level IV Analysts as identified
o Evaluate documentation for completeness and consistency, and assign additional actions as necessary to close the complaint file.
o Approve final complaint file for closure after all applicable actions are completed.
o Manage complaint workload to required backlog goals.
o Review and analyze lot documentation (DHRs) to determine if there are any anomalies that maybe related to reported product failures.
Escalate complaints to the Regulatory Post Market Surveillance Manager or Lead when new failure modes are encountered
Escalate complaints to the Post Market Investigation (PMI) group as required
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
Provide peer review and feedback of complaints and reports
Participate in new hire training and continuous Regulatory Compliance training as required
Participate in process improvement activities to continuously improve process effectiveness
Execute on projects as required
Perform other duties as directed
Skills and Job Requirements:

Education - Undergraduate degree in engineering, life science, or equivalent

Experience 2+ years of experience in medical device field, with experience or exposure in the following areas:
Knowledge and understanding with Medical Device Complaint files and quality record documentation
Knowledge and understanding of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements, etc.)
General technical and or clinical medical device knowledge

Skills: The following skills are required for this position:
Demonstrate strong written and verbal communication skills
Strong computer skills (Excel, Word, PowerPoint, database)
Efficient independent worker with ability to focus
Attention to detail
Demonstrate cross functional communication skills in email and in person
Excellent organizational and analytical skills
Ability to handle and manage workload independently
Prioritize numerous activities in a rapid paced environment
Contribute to team oriented tasks
Strong analytical skills
Strong interpersonal and decision making skills.

Competency / Training: The following competencies are essential for this position:
General understanding of Regulatory reporting requirements for Medical Devices and complaint system and process requirements.
General understanding of quality records requirements and how they apply to complaint files.
Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.