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Boston Scientific · 1 month ago

Product Complaint Analyst II

Arden Hills, MN

Full-time

Hybrid

Entry, Mid Level

$58K/yr - $110K/yr

2+ years exp

Boston Scientific is a leader in medical science, providing innovative solutions to improve patient lives. The Product Complaint Analyst II analyzes customer complaints and ensures compliance with regulatory standards, collaborating with various teams to support investigations and enhance product quality.

Health CareMedicalMedical Device

No H1B

Responsibilities

Review complaint communications and assess for regulatory compliance, reportability, and potential impact on patient safety and business operations

Apply clinical and technical knowledge related to product application to evaluate complaints

Investigate complaints by gathering and analyzing data from clinical staff, field representatives, internal employees, and laboratory analysis

Establish regulatory reportability decisions using event investigation tools and decision models

Participate in the development and modification of decision models as product technologies and therapies evolve

Write Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring accurate and timely submission to regulatory authorities

Apply appropriate event coding to support product performance tracking, collaborating with engineering, laboratory, and other internal stakeholders to review investigation findings

Compose written communications summarizing clinical observations, investigation results, product analysis, and corrective actions for internal and external audiences, as appropriate

Qualification

Regulatory report writingComplaint handling systemsClinical knowledgeData analysisAttention to detailCommunication skillsTeam playerTime managementOrganizational skills