Address
Form of workJOB DESCRIPTION
Top 3 things the manager is looking for:
MDR Experience
Previous healthcare experience
Med device company experience
Top 3 Tasks in Scope for this role:
Review incoming complaints from the field
Go back out to the field for further information on complaints
File regulatory reports
Location: Mounds View, MN Onsite work Wednesday and Thursday.
Hours: 40
Responsibilities may include the following and other duties may be assigned.
• Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
• Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
• Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.
• Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
Must Have: Minimum Requirements
• Bachelors degree required
• 0 years of experience required
