Boston Scientific · 2 weeks ago
Product Complaint Analyst III
Arden Hills, MN
Full-time
Onsite
Mid, Senior Level
$66K/yr - $125K/yr
5+ years expBoston Scientific is a leader in medical science dedicated to transforming lives through innovative medical solutions. The Product Complaint Analyst III role involves analyzing customer complaints related to Urology products and ensuring compliance with regulatory requirements while collaborating with various stakeholders.
Health CareMedicalMedical Device
No H1B
Responsibilities
Review complaint communications and assess complaints for regulatory reportability, and potential impacts to patient safety and business operations
Apply clinical knowledge, as related to product usage, to evaluate complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, laboratory analysis results, and other relevant sources
Establish regulatory reportability decisions using event investigation and regulatory decision models
Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations
Write Medical Device Reports (MDRs), Vigilance, and other regulatory reports, ensuring timely submission to the appropriate regulatory authorities
Accurately and consistently apply codes to events. Review coding and investigations with engineering, laboratory, and other internal staff, as appropriate
Effectively compose written communication, detailing the clinical observations, investigations and/or product analyses, and corrective actions, as applicable, to physicians and other end use customers
Review and approve work completed by others
Qualification
Required
Bachelor's Degree
Minimum of 5 years of experience in medical device complaint handling
Self-motivated, goal-driven and results-oriented team player
Excellent written and verbal communication skills
Ability to apply critical thinking
Excellent time management
Preferred
College Degree focus in Biology, Health Sciences, Biotechnology or Engineering preferred
Experience with SAS, PowerBI, or TrackWise applications
Experience reviewing scientific literature
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$10.01B2025-02-21Post Ipo Debt· $1.57B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
2026-02-04
Company data provided by crunchbase