Product Complaint Analyst I

About the Role

The Complaint Analyst I will help to analyze customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. The Complaint Analyst I will be responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. The Complaint Analyst I will communicate event investigation results via regulatory reports and written communications, as appropriate. In all actions, the Complaint Analyst I will demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Your Responsibilities Include

• Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
• Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations.
• Evaluate and investigate identified complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
• Collect, compile, and document regulatory reportability decisions using event investigation and regulatory decision models.
• Draft Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission 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.
• Draft written communications detailing clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physicians and other end use customers. Communications include determination/eligibility for warranty credit or unreimbursed medical payments.

What We're Looking For

Required Qualifications

• Bachelor's degree required
• Minimum of 1 year of experience in a health care, clinical, technical, scientific, and/or related field
• Ability to manage multiple dashboards, inputs and quickly shifting priorities.

Preferred Qualifications

• Experience in complaint handling
• Experience writing or submitting Medical Device Reports (MDRs)
• Experience with Medical Devices, Electrophysiology preferred
• Experience working in a Trackwise-based complaint handling system
• Experience with general Microsoft Programs (Excel, Word, Outlook, etc.)
• Strong analytical and problem-solving skills
• Excellent communication skills
• Strong organizational skills and attention to detail