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Boston Scientific · 12 hours ago

Product Complaint Analyst I

Arden Hills, MN

Full-time

Hybrid

Entry Level

$51K/yr - $96K/yr

1+ years exp

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.

Health CareMedicalMedical Device

No H1B

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

Qualification

Complaint handlingMedical Device Reports (MDRs)Trackwise systemMicrosoft ProgramsAnalytical skillsProblem solvingCommunication skillsOrganizational skillsAttention to detail