Product Complaint Specialist (Must sit in PST)

Our Customer is a corporation that develops, manufactures, and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery. Founded in 1995, their goal was to create innovative, robotic-assisted systems that help empower doctors and hospitals to make surgery less invasive than an open approach. Working with the top medical professionals, they continue to develop new, minimally invasive surgical platforms and future diagnostic tools to help solve complex healthcare challenges around the world.

We are seeking a Product Complaint Specialist on a contract basis to help investigate customer complaints, make an initial reporting decision, and ensure completeness and consistency of complaint and related documentation.

What you’ll do:
• Investigating complaints daily.
• Complete new hire training and ongoing Regulatory Post Market Surveillance training as required.
• Follow and comply with company procedures and processes relating to complaint intake, assessment and reporting.
• Process, record and close assigned complaint handling activities in a timely manner.
• Perform the preliminary classification of complaints.
• Perform Failure Analysis investigation review and escalate complaints that require additional review.
• File Malfunction MDR Reports as identified
• Escalate Adverse Event or Incident reports as identified
• Evaluate documentation for completeness and consistency, and assign additional actions as necessary to close the complaint file.
• Approve final complaint file for closure after all applicable actions are completed.
• 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

Must Haves:
• 1+ years of experience in the medical device field, with experience or exposure in the following areas:
• Knowledge and basic understanding of Medical Device Complaint files and quality record documentation
• Knowledge and a 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 the information at hand and evaluate the need to obtain clarification and direction when necessary.
• General computer skills (Excel, Word, PowerPoint, database)
• Analytical skills
• Interpersonal and decision-making skills.
• Detail oriented and strong administrative skills including time management.

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

Hours & Location:
M-F, 40 hours/week. This role will be 100% remote but the candidate must work within the Pacific Standard Time zone.

Now for the Perks!
Health Benefits: Medical, Dental, Vision, Life (including spouse & child), 401k, STD/LTD, AD&D, and Commuter Benefits program.