PRODUCT COMPLAINT ASSOCIATE 3

Primary Function of Position:

The Regulatory Post Market Surveillance Coordinator investigates customer complaints, makes an initial reporting decision, and ensures completeness and consistency of complaint and related documentation.

Roles and Responsibilities:

This position has responsibility and authority for:
Investigating complaints daily:
o Complete RPMS new hire training and ongoing Regulatory Post Market Surveillance training as required.
o Follow and comply with company procedures and processes relating to complaint intake, assessment and reporting.
o Process, record and close assigned complaint handling activities in a timely manner.
o Perform the preliminary classification of complaints.
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 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.
Escalate complaints to the Regulatory Post Market Surveillance Manager or Supervisor 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 internal and external sources to gather additional information required for complaint investigation, including retrieval of RMA
Attend 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
Preferred Skills and Job Experience:

Education: Associates Degree, Bachelor's Degree or Master's Degree

Experience: 1+ years of experience in medical device field, with experience or exposure in the following areas:
Knowledge and basic understanding with Medical Device Complaint files and quality record documentation
Knowledge and basic understanding of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements, etc.)
General technical and or clinical medical device knowledge
General understanding of Regulatory Reporting requirements for Medical Devices and complaint system and process requirements for Regulatory Post Market Surveillance.
General understanding of quality record requirements and how they apply to complaint files and regulatory reports.
Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.
Skills:
Demonstrate strong written and verbal communication skills
General 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
Organizational and analytical skills
Ability to handle and manage workload independently
Prioritize numerous activities in a rapid paced environment
Contribute to team oriented tasks
Analytical skills
Interpersonal and decision-making skills.
Detail oriented and strong administrative skills including time management.