Product Complaint Analyst I

Additional Location(s):   N/A 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 will be posted from 7/22/26 - 7/27/26 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.   The Product Complaint Analyst I analyzes customer complaints to determine regulatory reportability and coordinates complaint-related activities with internal teams, field representatives and end users. This role is responsible for ensuring adherence to Good Manufacturing Practices (GMP), complaint handling requirements under the Code of Federal Regulations (CFR), and other applicable regulatory requirements. The Product Complaint Analyst I communicates investigation results through regulatory submissions and written customer communications, as appropriate.   In all actions, the Product Complaint Analyst I demonstrates a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality processes and procedures.   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: • Review complaint communications and assess regulatory compliance, reportability, and potential impact on patient safety and business operations. • Participate in the development and enhancement of regulatory decision models to support new products, therapies and evolving regulatory requirements. • Evaluate and investigate customer complaints by gathering relevant information from clinical staff, field representatives, internal partners and laboratory analyses. • Collect, compile and document regulatory reportability decisions using established investigation and regulatory decision models. • Prepare Medical Device Reports (MDRs), MedWatch reports, Vigilance reports and other regulatory submissions, ensuring timely reporting to applicable regulatory authorities. • Apply event coding to support product performance records and collaborate with engineering, laboratory and cross-functional teams to review investigations and coding accuracy. • Draft written communications summarizing clinical observations, investigation findings, product analyses and corrective actions, as appropriate, for physicians and other end users, including warranty and unreimbursed medical payment determinations.   Qualifications: Required qualifications: • Minimum of a bachelor's degree. • Minimum of less than one year's experience. Preferred qualifications: • Experience with complaint handling. • Experience preparing or submitting Medical Device Reports (MDRs). • Experience with medical devices; electrophysiology experience preferred. • Experience using a TrackWise-based complaint handling system. • Proficiency with Microsoft Office applications, including Excel, Word and Outlook. • Strong analytical and problem-solving skills. • Excellent written and verbal communication skills. • Strong organizational skills with exceptional attention to detail.   Requisition