Senior Product Analyst

Additional Locations US-CA-Carlsbad; US-CA-Valencia; US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove Senior Product Analyst – 12 Month Defined Term Position The Senior Product Analyst analyzes customer complaints to determine regulatory reportability and coordinates activities with internal teams, field representatives, and end‑use customers. The role ensures adherence to Good Manufacturing Practices (GMPs), complaint handling requirements under the Code of Federal Regulations (CFR), and applicable international regulations. Regulatory reports and written communications are prepared to report event investigation results as appropriate. Responsibilities 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 for physicians and other end‑use customers. Review complaint investigations and approve complaints for closure. Qualifications Required Qualifications Bachelor’s degree required with a minimum of 3 years’ experience, or master’s degree with 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 reports. Excellent written and verbal communication skills. Strong proficiency with Microsoft Office applications, including Excel, Word, and Outlook. Experience with PowerPoint, Microsoft Access, and complaint database applications such as GCMS or similar systems. Compensation & Benefits Minimum Salary: $75,100 Maximum Salary: $142,600 The compensation listed above and the value of core and optional employee benefits will vary based on the actual location of the position and other pertinent factors. Compensation will be commensurate with demonstrable level of experience and training, pertinent education, including licensure and certifications, and other relevant business or organizational needs. Equal Employment Opportunity Boston Scientific Corporation is an equal opportunity employer. All recruitment, hiring, assignment, promotion, compensation, and other personnel decisions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information, or any other protected class. #J-18808-Ljbffr Boston Scientific