Senior Product Analyst

Skip to main contentDashboardProfileJoin Talent NetworkSign InEnglishSingle PositionView All JobsSenior Product AnalystCarlsbad US-CA, United States | US-CA-Carlsbad, US-CA-Valencia, US-MA-Marlborough, US-MN-Arden Hills, US-MN-Maple Grove No longer accepting applications.Work ModeHybridRequisition ID630050Additional Location(s): US-CA-Carlsbad; US-CA-Valencia; US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple GroveDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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 is a 12 month defined term position.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 Senior Product Analyst analyzes customer complaints to determine regulatory reportability and coordinates activities with internal teams, field representatives and end-use customers. This role is responsible for adherence to Good Manufacturing Practices (GMPs), complaint handling requirements under the Code of Federal Regulations (CFR), and applicable international regulations. The Senior Product Analyst communicates event investigation results through regulatory reports and written communications, as appropriate.Boston Scientific complaint handling teams have developed an efficient and compliant model for processing complaints that has delivered strong results. The team-centered approach encourages employee involvement in optimizing processes and supports professional development through opportunities to expand skills aligned with future career goals.Your responsibilities will include:● Review complaint communications and assess regulatory compliance, reportability, and potential impact on patient safety and business operations.● Apply clinical knowledge related to product application to evaluate identified complaints.● Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees and laboratory analysis.● Establish regulatory reportability decisions using event investigation findings and regulatory decision models.● Participate in the development and modification of regulatory decision models to support product advancements and therapies while maintaining compliance with domestic and international regulations.● Author Medical Device Reports (MDRs), MedWatch reports, vigilance reports and other regulatory submissions, ensuring timely transmission to appropriate regulatory authorities.● Apply event coding to support product performance records and review coding and investigations with engineering, laboratory and other internal teams.● Compose written communications detailing clinical observations, investigations, product analyses and corrective actions, as applicable, for physicians and other end-use customers.● Review complaint investigations and approve complaints for closure.Qualifications:Required qualifications:● Bachelor’s degree required and a minimum of 3 years' experience, or master’s degree and a minimum of 2 years' experience.● Hands-on experience in medical device complaint handling.● Familiarity with medical device terminology, as well as anatomical and physiological terminology.● Ability to work independently with limited guidance and direction.● Self-motivated, goal-driven and results-oriented mindset.Preferred qualifications:● Previous complaint handling experience.● Previous experience supporting audits and inspections.● Previous experience with Medical Device Reports (MDRs).● Experience writing and filing MedWatch and vigilance...