Product Complaint Analyst III

bostonscientific•Valencia, MN

1d•$63,900 - $121,400•Hybrid

About The Position

Works in a fast-paced environment to analyze customer complaints for the Urology Complaint Management Center (CMC) to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Products within scope include men’s prosthetic urology, sacral neuromodulation (incontinence), prostate health, and surgical lasers. Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate. 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. Relocation assistance is not available for this position at this time. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Requirements

Bachelors Degree
Minimum of 5 years of experience in medical device complaint processing and reporting
Self-motivated, goal-driven and results-oriented team player
Excellent written and verbal communication skills
Ability to apply critical thinking
Excellent time management

Nice To Haves

College Degree focus in Biology, Health Sciences, Biotechnology or Engineering preferred
Experience with SAS, PowerBI, or TrackWise applications
Experience reviewing scientific literature

Responsibilities

Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
Apply clinical knowledge, as related to product application, to evaluate identified complaints.
Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
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), MedWatch, Vigilance, 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 the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers.
Approval of work completed by the team.