Product Complaint Analyst I
Boston Scientific is a global medical technology leader that transforms lives through innovative medical technologies. The Product Complaint Analyst I will analyze customer complaints to determine regulatory reportability and coordinate activities with various stakeholders while ensuring compliance with Good Manufacturing Practices (GMPs). This role emphasizes patient safety and product quality, requiring effective communication of investigation results.
Responsibilities
- 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 the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers
- Communications include determination/eligibility for warranty credit or unreimbursed medical payments
Skills
- Minimum of a Bachelors degree
- Minimum of less than one year of experience
- 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, ect)
- Strong analytical and problem solving skills
- Excellent communication skills
- Strong organizational skills and attention to detail
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