Senior Product Analyst

Senior Product Analyst

Work mode: Hybrid Onsite Location(s): Carlsbad, CA, US, 92011 Additional Location(s): US-CA-Carlsbad; US-CA-Valencia; US-MA-Marlborough; 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 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 reports. Excellent written and verbal communication skills. Strong proficiency with Microsoft Office applications, including Excel, Word and Outlook. Experience with PowerPoint, Microsoft Access, complaint database applications such as GCMS, or similar systems.

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered 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.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.