Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance 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: The Product Complaint Analyst evaluates customer complaints to determine which are regulatory reportable per the Code of Federal Regulations (CFR) and other international regulations. This role oversees all aspects of complaint handling, including the timely review of product feedback, analysis and investigation to gather pertinent information and communicate findings through regulatory reporting and written communication to key stakeholders. Your responsibilities will include: Assessing incoming complaint information to determine eligibility for medical device and vigilance reporting; ensure reports are complete, accurate, and submitted on time Ensuring policies and procedures comply with FDA and international regulations Interfacing with end users and collaborating with internal and external contacts to collect complaint information Maintaining awareness of new products, government regulations and requirements Performing other duties as assigned Required qualifications: Bachelor's degreein any engineering or science related discipline Minimum 2 years of experience working in medical device or similarly regulated industry Minimum 2 years of experience investigating product quality and patient-related complications (i.e serious injury) Preferred qualifications: Experience with TrackWise complaint handling system Experience managing regulatory submissions for medical device and vigilance reports (MDR/MDV) Knowledge of electrophysiology or ablation medical devices Strong interpersonal skills with the ability to work with cross-functional teams Organized and detail-oriented; ability to prioritize and manage competing priorities Strong written and verbal communicationskills with ability to present technical information Effective problem-solving and critical thinking analytical skills; results-driven Self-driven and self-motivated to learn and apply knowledge to produce results Requisition ID:588362 Among other requirements, Boston Scientific maintains specific prohibited substancetesting requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law. As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewardin place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code * 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination. Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran