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Job Title:

Regulatory Post Market Surveillance Coordinator - Sunnyvale, CA

Job Description:

Regulatory Post Market Surveillance Coordinator


Primary Function of Position:
The Regulatory Post Market Surveillance Coordinator investigates customer complaints, makes an initial reporting decision, provides failure analysis letters, and ensures completeness and consistency of complaint and related documentation.

Roles and Responsibilities:
This position has responsibility and authority for:

  • Investigating complaints daily:
    • Perform the preliminary classification of complaints and escalate complaints that require additional review.
    • 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.
    • Review and analyze lot documentation (DHRs) to determine if there are any anomalies that maybe related to reported product failures.
  • Escalate complaints to the Regulatory Post Market Surveillance Manager or Lead 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 Customer Service and hospitals to gather additional information required for complaint investigation, including retrieval of RMA
  • Create customer response letters as needed
  • Provide peer review and feedback of complaints and reports
  • Participate in 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

Skills and Job Requirements:
Education - Undergraduate degree in engineering, life science, or equivalent
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

Skills: The following skills are required for this position:

  • 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.

Competency / Training: The following competencies are essential for this position:

  • General and basic understanding of Regulatory reporting requirements for Medical Devices and complaint system and process requirements for post market surveillance.
  • General and basic understanding of quality records 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.

Job ID:
342503

Dept ID:
10573

Location:
Sunnyvale, CA
United States of America

Industry:
Online / Full App

Job Type:
Temp Position
Folder Group ID
258

Posted Date:11/19/2018

Domain:arna

Contact: lisa.burns@advantageresourcing.com

Apply for this Position

Job Title: Regulatory Post Market Surveillance Coordinator

Location: Sunnyvale, CA

Job Type: Temp Position

Reference ID: 342503

Posted Date: 11/19/2018

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