Product Complaint Analyst III

Additional Location(s): US-MN-Arden Hills; US-MN-Maple Grove

Diversity
- Innovation
- Caring
- Global Collaboration
- Winning Spirit
- High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

This role supports the Urology Complaint Management Center (CMC) in a fast-paced environment, analyzing customer complaints to determine regulatory reportability and coordinating activities with internal teams, field representatives and end-use customers. Products within scope include men’s prosthetic urology, sacral and tibial neuromodulation for incontinence, prostate health, and surgical lasers.

The role is responsible for adherence to Good Manufacturing Practices (GMPs), proper complaint handling in accordance with the Code of Federal Regulations (CFR) and other applicable governmental regulations, and communication of event investigation results through regulatory reports and written communications, as appropriate.

Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

• 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 identified complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees and laboratory analyses.
• Establish regulatory reportability decisions using event investigation and regulatory decision models.
• Participate in the development and modification of decision models as products and therapies advance to support consistent compliance with government-mandated regulations.
• Write Medical Device Reports (MDRs), Med Watch reports, Vigilance reports and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
• Apply codes to events to facilitate product performance records. Review coding and investigations with engineering, laboratory and other internal staff.
• Compose written communications detailing clinical observations, investigations and/or product analyses and corrective actions, as applicable, for physicians and other end-use customers.
• Review and approve work completed by the team.

• University degree or equivalent education.
• Minimum of 5 years' 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.

• College degree with a focus in biology, health sciences, biotechnology or engineering.
• Experience with SAS, Power BI or Track Wise applications.
• Experience reviewing scientific literature.

The…