Product Complaint Analyst III

Product Complaint Analyst III

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.

About the role: 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.

Your responsibilities will include: 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.

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