Product Complaint Analyst I
Boston Scientific is a leading company in the health industry, providing innovative solutions and support to enhance patient care. The Product Complaint Analyst I will analyze customer complaints to determine regulatory reportability and ensure compliance with Good Manufacturing Practices and governmental regulations.
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, cardiology 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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