Product Complaint Analyst II

About The Role

The Product Complaint Analyst II will work 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. and 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 II will communicates 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. 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.

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.

Required Qualifications

• 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 Qualifications

• 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

Pay

Minimum Salary: $59,900; Maximum Salary: $113,800. The anticipated compensation 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).