Product Complaint Analyst III

Boston Scientific • Arden Hills, MN

3d • $65,800 - $125,000 • Hybrid

About The Position

The Product Complaint Analyst III supports Boston Scientific’s Urology Complaint Management Center in a fast-paced environment. The role analyzes customer complaints to determine regulatory reportability and coordinates activities with internal teams, field representatives, and end-use customers. Products in scope include men’s prosthetic urology, sacral and tibial neuromodulation for incontinence, prostate health, and surgical lasers.

The position is responsible for adhering to Good Manufacturing Practices and handling complaints in accordance with the Code of Federal Regulations and other applicable governmental regulations. It communicates event investigation results through regulatory reports and written communications, as appropriate. The role follows a hybrid work model, requiring employees to work in a local office at least three days per week. Boston Scientific does not offer visa sponsorship or relocation assistance for this position.

Requirements

• University degree or equivalent education.
• At least 5 years of experience in medical device complaint handling.
• Self-motivated, goal-driven, and results-oriented approach, with the ability to work effectively as part of a team.
• Excellent written and verbal communication skills.
• Ability to apply critical thinking.
• Excellent time-management skills.

Nice To Haves

• College degree focused in biology, health sciences, biotechnology, or engineering.
• Experience with SAS, Power BI, or TrackWise applications.
• Experience reviewing scientific literature.

Responsibilities

• Review complaint communications and assess regulatory compliance, reportability, and potential impact on patient safety and business operations.
• Apply clinical knowledge related to product applications to evaluate complaints, gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analyses.
• Establish regulatory reportability decisions using event investigations and regulatory decision models.
• Participate in developing and modifying decision models as products and therapies advance to support consistent compliance with government-mandated regulations.
• Write Medical Device Reports (MDRs), MedWatch reports, Vigilance reports, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
• Apply event codes to facilitate product performance records and review coding and investigations with engineering, laboratory, and other internal staff.
• Compose written communications detailing clinical observations, investigations, product analyses, and corrective actions, as applicable, for physicians and other end-use customers.
• Review and approve work completed by the team.

What This Job Offers

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