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MDR/ Complaint Handling Specialist - 62882057 - TT

Job Code: 62882057
Job Location: Arden Hills, MN
Category: Business
Last Updated: 06/06/2019
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Job Description:
In this role, you will analyze customer complaints to determine which are regulatory reportable and coordinate activities with internal, field, and end use customers.
Job Responsibilities:
• Review complaint communications and assess for regulatory compliance, report ability, and potential impact to patient safety and business operations.
• Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
• Communicate with internal/external customers to gain insight into each complaint event
• Ensure complaint records, Regulatory reports, and applicable complaint handling documents are compliant with Good Documentation Practices (GDP), global regulatory standards and internal procedures.
• Write Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transition to the appropriate regulatory authorities.
• Apply codes to events to facilitate product performance records. Review coding and investigations with engineering, laboratory, and other internal staff.
• Compose written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers.
• Bachelor’s degree
• Experience with Complaint Handling
• Proficiency with computer application such as Microsoft Office (Excel, Word, Outlook,)
• Excellent written and verbal communication skills are essential
• Must be self-motivated, goal-driven and results-oriented team player
Preferred Qualifications:
• Direct experience in writing and filing MDR and MDV reports
• Experience with Electrophysiology medical devices
• Familiarity with medical device terminology
• Familiarity with Anatomy/Physiology terminology
• Critical thinking and good time management
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or
Please reference job # 62882057TT
Equal Opportunity Employer


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Entegee is an equal opportunity employer. Entegee considers applicants for all positions without discrimination on the basis of race, color, religion, sex, national origin, age, marital or veteran status, disability, or any other legally protected status. No question in the website is used for the purpose of limiting or excluding any applicant's consideration for employment on any basis prohibited by local, state, or federal law.

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