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Regulatory Post Market Surveillance Coordinator

Job Post Index 21E27A-Sy##
Location Sunnyvale, CA
Description: Job Description
  • Investigates customer complaints, makes an initial reporting decision, and ensures completeness and consistency of complaint and related documentation.
  • Investigating complaints daily.
  • Complete RPMS new hire training and ongoing Regulatory Post Market Surveillance training
  • 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
  • Evaluate documentation for completeness and consistency, and assign additional actions 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
  • 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
  • Participate in process improvement activities to continuously improve process effectiveness.
Skills: Qualifications
  • Associates Degree; OR
  • Bachelor's Degree; OR
  • Master's Degree
  • Undergrad degree in Science or Engineering is preferred.
  • At least 2 years of experience in complaint handling to FDA.
  • 1+ years of experience in medical device field
  • Knowledge and basic understanding with Medical Device Complaint files and quality record documentation.
  • Knowledge of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements, etc.)
  • Understanding of Regulatory Reporting requirements for Medical Devices and complaint system and process requirements for Regulatory Post Market Surveillance.
  • 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.
  • General technical and or clinical medical device knowledge.
  • Able to be thorough in their investigations.
  • General computer skills (Excel, Word, PowerPoint, database).
  • Criminal knowledge and critical thinking skills
  • Demonstrate cross functional communication skills in email and in person.
  • Able to prioritize numerous activities in a rapid paced environment independently
  • Strong administrative skills
  • Time management skills/Able to meet deadlines
  • Must have strong analytical skills
  • Organized.
  • Decision-making skills.
  • Team oriented
  • Keen attention to detail.
  • Strong documentation skill
  • Demonstrate strong written and verbal communication skills.
  • Trackwise, SAP CRM experience would be helpful

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