Product Complaint Analyst II

Additional Location(s): US-MN-Arden Hills; US-CA-Irvine; US-MA-Marlborough; US-MN-Maple Grove Diversity
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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.

Your responsibilities will include:

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 education1+ 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

Requisition  Salary: $ 59900

Maximum Salary: $ 113800

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see 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…