Medical Device Complaint Specialist (Temporary) Job at PRISMATIK DENTALCRAFT, INC., Irvine, CA

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  • PRISMATIK DENTALCRAFT, INC.
  • Irvine, CA

Job Description

Prismatik Dentalcraft is a division of Glidewell Dental.

Essential Functions :

  • Evaluates event(s) to determine if it qualifies as a complaint.
  • Assesses complaint information provided, gather any missing information for complainant file, and escalates complaint to appropriate parties as needed.
  • Manages customer relationship and expectations during course of complaint investigation and resolution process.
  • Reviews potential reportable events to determine if regulatory filings are required.
  • Ensures compliance with all federal and international regulations applicable to manufactured medical devices.
  • Maintains and completes complaint files for all customer complaints according to procedures.
  • Maintains awareness of new products and government regulations and requirements.
  • Documents and completes complaints in timely manner.
  • Prepares and submits final customer correspondence as required.
  • Performs other related duties and projects as business needs require at direction of management.

Education and Experience:

  • Bachelor’s degree in science, engineering, or equivalent relevant experience preferred.
  • Minimum two (2) years of experience within regulatory affairs or medical device reporting.
  • Medical device experience preferred.
  • Understanding and interpretation of domestic and international complaint handling and reporting requirements required.

Pay Range : $25.00 to $35.00/hr.

Job Tags

Temporary work,

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