Senior Product Complaint Analyst

Additional Locations:  US-MN-Arden Hills; US-MN-Mankato/Rochester   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.   About the role:   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.   Everyone at Boston Scientific works toward one goal: transforming lives by addressing the most critical challenges in the medical device industry. Patient care is at the heart of everything we do, and ensuring quality, compliance and positive outcomes is essential to delivering on that commitment.   As a Senior Product Complaint Analyst, you will be a key member of a high-performing team committed to advancing product quality, patient safety and regulatory compliance across global markets. In this role, you will evaluate and investigate customer complaints, prepare Medical Device Reports (MDRs) and Medical Device Vigilance (MDV) submissions, and support post-market surveillance activities within the Cardiac Diagnostics Complaint Management Team. Working closely with cross-functional partners, you will help resolve complex product and quality issues while ensuring timely, accurate and compliant complaint handling.   You will play a critical role in maintaining compliance with Good Manufacturing Practices (GMPs), divisional Standard Operating Procedures (SOPs), Work Instructions (WIs), and applicable global regulatory requirements, including 21 CFR Part 820, EU MDR, MDSAP and ISO 13485. By leveraging data-driven insights and analytical problem-solving skills, you will identify emerging trends and risks, drive continuous process improvements, and support informed business and regulatory decision-making.   This is an exciting opportunity to make a meaningful impact on health care outcomes worldwide while contributing to a collaborative, innovative and mission-driven culture that values professional growth, teamwork and shared success.   Work model, sponsorship, relocation: 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.   Your responsibilities will include: ● Promote a culture of quality, accountability, collaboration and continuous improvement. ● Review complaints and regulatory assessments to determine reportability, compliance and potential impact on patient safety and product quality. ● Investigate complaints by gathering and analyzing information from clinical staff, field representatives, internal stakeholders and laboratory evaluations. ● Establish regulatory reporting decisions using hazard analyses, DFMEAs, investigation findings and regulatory decision models. ● Author and submit MDRs, MDVs, MedWatch reports and other regulatory submissions in accordance with global regulatory requirements. ● Apply and review complaint coding to support accurate product performance trending, and collaborate with engineering, laboratory and cross-functional teams on investigation outcomes. ● Prepare clear, concise written communications summarizing complaint investigations, clinical assessments, product analyses and corrective actions. ● Serve as a subject matter expert for complaint