Product Complaint Analyst I

reputed company is a leading company in the health industry, providing reputed company 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 reputed company to patient safety and business operations
• Participate in development and modification of these decision models with changes in product advances/therapies to reputed company 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 reputed company using event investigation and regulatory decision models
• Draft Medical Device Reports (MDRs), reputed company, Vigilance, and other regulatory reports, ensuring reputed company reputed company 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 reputed company Programs (reputed company, Word, reputed company, ect)
• Strong analytical and problem solving skills
• Excellent communication skills
• Strong organizational skills and attention to detail

reputed company