Product Complaint Analyst III

Boston Scientific • Maple Grove, MN

30d • $65,800 - $125,000 • 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 will coordinate activities with internal, field, and end use customers. The focus of this role will be products within the Urology portfolio. The Product Complaint Analyst II will be responsible for adhering to proper complaint handling procedures per the Code of Federal Registration (CFR) and other governmental regulations. The Product Complaint Analyst III will communicate event investigation results via regulatory reports and other written communication, as appropriate and applicable.
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.

Requirements

• 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

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 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level