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Post Market Surveillance

Company: Roth Staffing
Location: Mountain View
Posted on: June 20, 2022

Job Description:

We have an immediate opening for a Post Market Surveillance with the below background.Job Title: Post Market Surveillance Location: Mt. View, CADirect Hire RESPONSIBILITIES

  • Oversee and maintain complaint handling process supporting both Headquarters and Pascal divisions.
  • Review incoming complaints, conduct investigations, follow up with customers, document relevant data, and evaluate and close complaint records.
  • Review, document and evaluate post-market feedback; escalate feedback to Engineering and Management as appropriate.
  • Work collaboratively with the QE and QA Manager to generate timely trend analysis and reporting.
  • Host and lead monthly cross-functional review of adverse events.
  • Work with Clinical Affairs to review and document serious adverse events identified from the literature review.
  • Work with Marketing and Regulatory Affairs to prepare and issue customer surveys and document results.
  • Participate in compilation, revision, and review of Clinical Evaluation Reports (CERs).
  • Continually evaluate post-market surveillance procedures and processesQUALIFICATIONS
    • BS or BA degree in science or engineering-related field preferred.
    • 5+ years of experience performing post-market surveillance activities including complaint handling, serious adverse events, and vigilance reporting.
    • Knowledge of applicable serious adverse event reporting requirements in MDSAP participating countries (e.g. USA, Canada, Brazil, Japan, and Australia).
    • Excellent written and spoken English skills; additional languages a plus.
    • Computer literacy is required; proficiency in MS Office Suite and the ability to learn ERP and PLM processes and other systems as needed to perform the duties of the position.Please email your resume to kinguyen@ledgent.com for consideration.Thank youKim

Keywords: Roth Staffing, Mountain View , Post Market Surveillance, Other , Mountain View, California

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