Product Complaint Analyst I

Boston Scientific•Arden Hills, MN

1d•$51,000 - $96,900•Hybrid

About The Position

The Product Complaint Analyst I analyzes customer complaints to determine regulatory reportability and coordinates complaint-related activities with internal teams, field representatives and end users. This role is responsible for ensuring adherence to Good Manufacturing Practices (GMP), complaint handling requirements under the Code of Federal Regulations (CFR), and other applicable regulatory requirements. The Product Complaint Analyst I communicates investigation results through regulatory submissions and written customer communications, as appropriate. In all actions, the Product Complaint Analyst I demonstrates a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality processes and procedures.

Requirements

Minimum of a bachelor's degree.
Minimum of less than one year's experience.

Nice To Haves

Experience with complaint handling.
Experience preparing or submitting Medical Device Reports (MDRs).
Experience with medical devices; electrophysiology experience preferred.
Experience using a TrackWise-based complaint handling system.
Proficiency with Microsoft Office applications, including Excel, Word and Outlook.
Strong analytical and problem-solving skills.
Excellent written and verbal communication skills.
Strong organizational skills with exceptional attention to detail.

Responsibilities

Review complaint communications and assess regulatory compliance, reportability, and potential impact on patient safety and business operations.
Participate in the development and enhancement of regulatory decision models to support new products, therapies and evolving regulatory requirements.
Evaluate and investigate customer complaints by gathering relevant information from clinical staff, field representatives, internal partners and laboratory analyses.
Collect, compile and document regulatory reportability decisions using established investigation and regulatory decision models.
Prepare Medical Device Reports (MDRs), MedWatch reports, Vigilance reports and other regulatory submissions, ensuring timely reporting to applicable regulatory authorities.
Apply event coding to support product performance records and collaborate with engineering, laboratory and cross-functional teams to review investigations and coding accuracy.
Draft written communications summarizing clinical observations, investigation findings, product analyses and corrective actions, as appropriate, for physicians and other end users, including warranty and unreimbursed medical payment determinations.