Product Complaint Analyst II

Boston Scientific; Arden Hills (MN); Hybrid; USD 60,000 - 114,000; Full time

Job summary

Boston Scientific Minnesota is seeking a Product Complaint Analyst II to evaluate incoming information, determine regulatory reportability, and coordinate with internal teams, field personnel and end-use customers.

The role ensures complete, accurate, and timely submission of Medical Device Reports (MDRs) and vigilance reports (MDVs) while adhering to GDPs and CFR requirements. A hybrid work model applies with in-office presence at least three days weekly.

Qualifications

• Bachelor's degree required.
• Minimum of 2 years' experience in a health care, clinical, technical, scientific or related field.
• Strong attention to detail and ability to manage multiple dashboards.

Responsibilities

• Apply FDA and other regulatory requirements to investigations and reporting.
• Evaluate information to determine eligibility for MDRs and vigilance reporting.
• Ensure complete, accurate and timely submission of MDRs and MDVs.
• Collaborate with internal/external contacts to collect complaint information.
• Maintain awareness of new products and government regulations.
• Perform other duties as assigned.

Skills

Dashboards management

Attention to detail

Critical thinking

Communication skills

Regulatory knowledge

Education

Bachelor's degree

Tools

TrackWise

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 II analyzes customer complaints to determine regulatory reportability and coordinates activities with internal teams, field personnel and end-use customers. This role is responsible for adherence to good documentation practices (GDPs) and complaint handling requirements under the Code of Federal Regulations (CFR) and other applicable international regulations. The Product Complaint Analyst II communicates event investigation results through regulatory reports and written communications, as appropriate.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:• Apply policies and procedures to comply with U.S. Food and Drug Administration (FDA) and outside the U.S. regulations.• Evaluate incoming information to determine eligibility for Medical Device Reporting and vigilance reporting.• Ensure complete, accurate and timely submission of Medical Device Reports (MDRs) and vigilance reports (MDVs).• Interface and collaborate with internal and external contacts to efficiently collect complaint information.• Complete continuous compliance training in a timely manner.• Maintain awareness of new products, government regulations and requirements.• Perform other duties as assigned.Qualifications:Required qualifications:• Bachelor's degree.• Minimum of 2 years' experience in a health care, clinical, technical, scientific or related field.• Ability to manage multiple dashboards and inputs while adapting to rapidly shifting priorities.Preferred qualifications:• Knowledge of interventional cardiology medical devices.• Experience with a TrackWise-based complaint handling system.• Experience with MDR and MDV submissions.• Experience evaluating and investigating patient complication and death events.• Medical device industry experience.• Post-market or quality experience.• Strong attention to detail.• Critical-thinking skills.• Excellent written and verbal communication skills.• Self-motivated, goal-driven and results-oriented team player.Requisition ID: 635266Minimum Salary: $ 59900Maximum Salary: $ 113800The 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.