Product Complaint Analyst II

Boston Scientific • Arden Hills, MN

88d • $59,900 - $113,800 • Hybrid

About The Position

The Product Complaint Analyst II works in a fast-paced environment analyzing customer complaints for the Urology Complaint Management Center (CMC), determining regulatory reportability, and coordinating activities with internal teams, field representatives, and end users. The role focuses on products in the Urology portfolio and requires adherence to complaint-handling procedures under the Code of Federal Regulations (CFR) and other governmental regulations. The analyst communicates investigation results through regulatory reports and other written communications, as appropriate.

This role follows a hybrid work model, with employees required to work in a local office at least three days per week. Relocation assistance and employment-visa sponsorship are not available.

Requirements

• Bachelor’s degree or equivalent education.
• At least 1 year of experience in medical device complaint processing and reporting.
• Excellent written and verbal communication skills.

Nice To Haves

• Self-motivated, goal-driven, results-oriented team player.
• Critical thinking and good time-management skills.
• College degree focused in Biology, Health Sciences, Biotechnology, or Engineering.

Responsibilities

• Review complaint communications and assess complaints for regulatory reportability and potential effects on patient safety and business operations.
• Apply clinical knowledge of product use to evaluate complaints and investigate them by gathering data from clinical staff, field representatives, internal employees, laboratory analyses, and other relevant sources.
• Make regulatory reportability decisions using event investigations and regulatory decision models.
• Participate in developing and modifying decision models to reflect product and therapy advances and maintain compliance with government regulations.
• Write Medical Device Reports (MDRs), Vigilance reports, and other regulatory submissions, and ensure timely submission to the appropriate authorities.
• Apply event codes accurately and consistently, and review coding and investigations with engineering, laboratory, and other internal staff as appropriate.
• Prepare written communications for physicians and other end users describing clinical observations, investigations, product analyses, and corrective actions, as applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level