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.

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