Product Complaint Analyst I

Boston Scientific • Maple Grove, MA

4d • Hybrid

About The Position

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

This position follows a hybrid work model, requiring employees to work in a local office at least three days per week. Relocation assistance and employment visa sponsorship are not available. The position is classified as safety-sensitive and requires a prohibited substance test. Compensation is listed as $51,000–$96,900, with actual compensation varying based on location and other relevant factors. Eligible compensation may include overtime or shift differentials for non-exempt roles and bonus or long-term incentives, subject to applicable plans and requirements.

Requirements

• Bachelor’s degree or equivalent education.
• Excellent written and verbal communication skills.

Nice To Haves

• At least one year of experience in medical device complaint processing and reporting.
• Self-motivated, goal-driven, results-oriented team player.
• Critical-thinking and 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 impacts on patient safety and business operations.
• Apply clinical knowledge related to product usage when evaluating complaints.
• Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, laboratory analysis results, and other relevant sources.
• Establish regulatory reportability decisions using event investigation and regulatory decision models.
• Participate in developing and modifying decision models to reflect product advances and therapies and maintain compliance with government-mandated regulations.
• Write Medical Device Reports (MDRs), Vigilance reports, and other regulatory reports, ensuring timely submission to the appropriate regulatory authorities.
• Accurately and consistently apply codes to events.
• Review coding and investigations with engineering, laboratory, and other internal staff as appropriate.
• Compose written communications for physicians and other end-use customers describing clinical observations, investigations or product analyses, and corrective actions as applicable.

What This Job Offers

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