Product Complaint Analyst III

Boston Scientific Gruppe; Arden Hills (MN); On-site; USD 66,000 - 125,000; Full time

Job summary

Boston Scientific is seeking a Regulatory Complaint Specialist to support the Urology Complaint Management Center in a fast-paced environment. You will analyze customer complaints for regulatory reportability, gather data from multiple sources, and communicate investigations and outcomes to internal teams and end-use customers.

Role requires a university degree and at least 5 years of medical device complaint handling, with strong writing, communication, and critical thinking skills.

Qualifications

• University degree or equivalent education.
• Minimum of 5 years' experience in medical device complaint handling.
• Self-motivated, goal-driven and results-oriented approach with the ability to work effectively as part of a team.
• Excellent written and verbal communication skills.
• Ability to apply critical thinking.
• College degree with a focus in biology, health sciences, biotechnology or engineering.
• Experience with SAS, Power BI or TrackWise applications.
• Experience reviewing scientific literature.

Responsibilities

• Review complaint communications and assess regulatory compliance and reportability.
• Investigate complaints by gathering data from clinical staff, field representatives, internal employees and laboratory analyses.
• Establish regulatory reportability decisions using event investigation and regulatory decision models.
• Participate in the development and modification of decision models as products advance to support compliant regulations.
• Write MDRs, MedWatch and other regulatory reports and transmit to authorities.
• Apply codes to events to facilitate product performance records and review with engineering and staff.
• Compose written communications detailing observations and actions for physicians and end-use customers.
• Review and approve work completed by the team.

Skills

Excellent written and verbal comms

Critical thinking

Self-motivated

Teamwork

Education

University degree or equivalent education

Biology/Health sciences/Engineering focus

Experience with medical devices

Tools

SAS

Power BI

TrackWise

Job description

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:

This role supports the Urology Complaint Management Center (CMC) in a fast-paced environment, analyzing customer complaints to determine regulatory reportability and coordinating activities with internal teams, field representatives and end‑use customers. Products within scope include men’s prosthetic urology, sacral and tibial neuromodulation for incontinence, prostate health, and surgical lasers.

The 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 governmental regulations, and communication of event investigation results through regulatory reports and written communications, as appropriate.

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.

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.

Apply clinical knowledge related to product applications to evaluate identified complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees and laboratory analyses.

Establish regulatory reportability decisions using event investigation and regulatory decision models.

Participate in the development and modification of decision models as products and therapies advance to support consistent compliance with government‑mandated regulations.

Write 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. Review coding and investigations with engineering, laboratory and other internal staff.

Compose written communications detailing clinical observations, investigations and/or product analyses and corrective actions, as applicable, for physicians and other end‑use customers.

Review and approve work completed by the team.

Qualifications:

Required qualifications:

University degree or equivalent education.

Minimum of 5 years' experience in medical device complaint handling.

Self‑motivated, goal‑driven and results‑oriented approach with the ability to work effectively as part of a team.

Excellent written and verbal communication skills.

Ability to apply critical thinking.

Preferred qualifications:

College degree with a focus in biology, health sciences, biotechnology or engineering.

Experience with SAS, Power BI or TrackWise applications.

Experience reviewing scientific literature.

Requisition ID:633893

Minimum Salary:$65800

Maximum Salary: $125000

The 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 byprovidinga 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,neurologicaland 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 specificprohibited substancetest 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.

Nearest Major Market: Minneapolis
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