PRODUCT COMPLAINT ASSOCIATE 3

Sunnyvale, CA 94086

Posted: 05/27/2020 Employment Type: Contract Industry: Regulatory Affairs & Compliance Job Number: 7852

Job Description


Our client manufactures and markets robotic products designed to improve clinical outcomes of patients.


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.

Job Requirements

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.

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