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Job Title:

Regulatory Post Market Surveillance Specialist - Sunnyvale, CA

Job Description:

Regulatory Post Market Surveillance Specialist, Operations

Primary Function of Position:
The Post Market Surveillance Operations Specialist role will assist the operations team within the Post Market Surveillance department with tasks needed to drive the daily business needs. Tasks include creating failure analysis letters, device manufacturing records review, creating reports and other requests as needed.

In addition, this position may assist with customer complaint assessments and investigations. Including performing follow-ups with customers and ensuring completeness and consistency of complaints and related documentation.

Roles and Responsibilities:
This position has responsibility for:

  • Creating failure analysis letters with complaint and RMA information as well as reference to the device instructions for use.
  • Device manufacturing record review in relation to complaints and returned devices to determine if any correlation exists
  • Escalation of requests or records based on reviews or findings, and customer feedback
  • Drafting customer letters for unique failure modes or specific requests related to return history, credit history, etc.
  • Creating reports related to complaints or returns, and related information, as needed
  • Assist with quality monitoring or review of complaints and related data
  • Assist with complaint assessment and investigations including
    • 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
    • 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
    • Interface with Customer Service and hospitals to gather additional information required for complaint investigation, including retrieval of RMA
  • 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 – 2+ years of experience in medical device field, with experience or exposure in the following areas:

  • Knowledge and understanding with Medical Device Complaint files and quality record documentation
  • Knowledge and understanding of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements, etc.)
  • General technical and or clinical medical device knowledge a plus

Skills: The following skills are required for this position:

  • Demonstrate strong written and verbal communication skills
  • Strong computer skills (Excel, Word, PowerPoint, database)
  • Efficient independent worker with ability to focus
  • Attention to detail
  • Task oriented
  • Critical thinking and problem-solving skills
  • Active learning – understanding how new information impacts future decision-making
  • Ability to monitor personal performance to make necessary improvements or changes
  • Demonstrate cross functional communication skills in email and in person
  • Excellent organizational and planning skills
  • Ability to handle and manage workload independently
  • Prioritize numerous activities in a rapid paced environment
  • Contribute to team oriented tasks
  • Strong analytical skills
  • Strong interpersonal and decision making skills.


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

  • General understanding of Regulatory reporting requirements for Medical Devices and complaint system and process requirements.
  • General understanding of quality records requirements and how they apply to complaint files.
  • Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.

Job ID:

Dept ID:

Sunnyvale, CA
United States of America

Online / Full App

Job Type:
Temp Position
Folder Group ID

Posted Date:9/11/2018



Apply for this Position

Job Title: Regulatory Post Market Surveillance Specialist

Location: Sunnyvale, CA

Job Type: Temp Position

Reference ID: 338745

Posted Date: 9/11/2018

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