Product Complaint Analyst I

Boston Scientific; Arden Hills (MN); Hybrid; USD 51,000 - 97,000; Full time

Job summary

Boston Scientific is seeking a Product Complaint Analyst I to analyze customer complaints for regulatory reportability and ensure GMP compliance. The role involves coordinating with internal teams, field representatives and end-use customers, with a hybrid work model requiring in-office presence at least three days a week.

You will draft MDRs, MedWatch and vigilance reports, communicate investigation results, and ensure timely submission to authorities while maintaining a focus on patient safety

Qualifications

• Bachelor's degree required.
• Less than one year of experience preferred.
• Experience with complaint handling and regulatory reporting is a plus.
• Experience writing or submitting Medical Device Reports (MDRs) is preferred.

Responsibilities

• Review complaint communications for regulatory reportability and impact on patient safety.
• Gather data from clinical staff, field representatives and internal teams for investigations.
• Draft regulatory reports (MDRs, MedWatch, Vigilance) and supporting communications.
• Apply coding to events and review with engineering and lab staff.
• Prepare written communications detailing observations and corrective actions.

Skills

Analytical skills

Communication skills

Organizational skills

Education

Bachelor's degree

Tools

TrackWise

Excel

Word

Outlook

Job description

Additional Location(s): N/ADiversity - 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.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.Requisition ID: 633515Minimum Salary: $ 51000Maximum Salary: $ 96900The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—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. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.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. Learn more at www.bostonscientific.com and follow us on LinkedIn.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.Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.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. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.