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Ref No.: 20-00376
Category: Clinical Affairs
Location: Sunnyvale, California
Primary Skills: Complaint Handling, Reporting Decision, Documentation, Medical Device Reporting
Duration: 10+ Months (Possible Extension)       
Contract Type: W2 Only
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:
  • Complete RPMS 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.
  • 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.
    To follow up with any questions, please contact Sneha at 408-512-2459.

Akraya is an award-winning IT staffing firm and the staffing partner of choice for many leading companies across the US. We offer comprehensive benefits including Health Insurance (medical, dental, and vision), Cafeteria Plan (HSA, FSA, and dependent care), 401(k) (enrollment subject to eligibility), and Sick Pay (varies based on city and state laws).

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Akraya is committed to equal treatment and opportunity in all aspects of recruitment, selection, and employment without regard to gender, race, religion, national origin, ethnicity, disability, gender identity/expression, sexual orientation, veteran or military status, or any other category protected under the law. Akraya is an equal opportunity employer; committed to a community of inclusion, and an environment free from discrimination, harassment, and retaliation.