Boston Scientific · 1 day ago
Product Complaint Analyst II
Arden Hills, MN
Full-time
Onsite
Entry Level
$60K/yr - $114K/yr
1+ years expBoston Scientific is a leader in medical science committed to solving significant health industry challenges. The Product Complaint Analyst II will analyze customer complaints related to the Urology portfolio, ensuring compliance with regulatory standards and communicating findings effectively.
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
Qualification
Required
Bachelor's degree or equivalent education
1+ years of experience in medical device complaint processing & reporting
Excellent written and verbal communication skills are essential
Preferred
Self-motivated, goal-driven and results-oriented team player
Critical thinking and good time management skills
College Degree focus in Biology, Health Sciences, Biotechnology or Engineering preferred
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
$10.02B2025-02-21Post Ipo Debt· $1.58B
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
2026-01-22
Company data provided by crunchbase