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 Electrophysiology Complaint Management Center (CMC) to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. 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.

Your responsibilities will include: Ability to apply clinical knowledge to review complaint communications and laboratory analysis to apply event coding, assess for regulatory compliance reportability, and potential impact to patient safety and business operations. Performs quality review and approval of records to ensure accuracy and compliance. Works independently guided by company policies, guidelines and procedures, receiving guidance on complex and unprecedented problems. Ability to participate in onboarding, training, and continuous improvement initiatives. Ability to provide constructive guidance and coaching to new or less experienced analysts, providing actionable feedback that supports skill development and builds confidence. Solves a range of problems of varying scope and complexity, generally applying existing solutions, while exercising autonomy or applying judgment based on experience to develop new solutions.

Required qualifications: Bachelor's Degree or equivalent combination of education and experience will be considered in lieu of degree Minimum of 3 years of experience in medical device industry and reporting Self-motivated, goal-driven and results-oriented team player Excellent written and verbal communication skills Ability to apply critical thinking and sound judgment in complex situations Proven ability to manage time effectively and prioritize tasks to meet deadlines Preferred qualifications: College Degree focus in Biology, Health Sciences, Biotechnology or Engineeringpreferred Experience with SAS, PowerBI, or TrackWise applications Experience reviewing scientific literature