Product Complaint Analyst I

Product Complaint Analyst I

Work mode: Hybrid Onsite Location(s): Arden Hills, MN, US, 55112 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.

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 will analyze customer complaints to determine regulatory reportability and coordinate activities with internal teams, field representatives and end-use customers. This role is responsible for adherence to Good Manufacturing Practices (GMPs), proper complaint handling in accordance with the Code of Federal Regulations (CFR) and other applicable government regulations. The Product Complaint Analyst I will communicate event investigation results through regulatory reports and written communications, as appropriate. In all actions, the Product Complaint Analyst I will demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other 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 modification of decision models as products and therapies advance to maintain consistent compliance with government-mandated regulations. Evaluate and investigate identified complaints by gathering sufficient data from clinical staff, field representatives, internal employees and laboratory analyses. Collect, compile and document regulatory reportability decisions using event investigation and regulatory decision models. Draft Medical Device Reports (MDRs), MedWatch reports, Vigilance reports and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities. Apply codes to events to facilitate product performance records and review coding and investigations with engineering, laboratory and other internal staff. Draft written communications detailing clinical observations, investigations and/or product analyses and corrective actions, as applicable, for physicians and other end-use customers. Communications may include determinations of eligibility for warranty credit or unreimbursed medical payments.

Qualifications: Required qualifications: Bachelor's degree. Less than one year of experience. Preferred qualifications: Experience in complaint handling. Experience writing or submitting Medical Device Reports (MDRs). Experience with medical devices; electrophysiology experience preferred. Experience working in a TrackWise-based complaint handling system. Experience with Microsoft programs, including Excel, Word and Outlook. Strong analytical and problem-solving skills. Excellent communication skills. Strong organizational skills and attention to detail.

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.