Product Complaint Analyst II

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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, 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 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.What we’re looking for:University degree or equivalent education.1+ years of experience in medical device complaint handling.Preferred Qualifications:Excellent written and verbal communication skills are essential.Must be 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 ID:

588759Among other requirements, Boston Scientific maintains specific prohibited substance testing 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.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 rewarding place for our employees to work and reflect the patients, customers, and communities we serve.Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran’s status, age, mental or physical disability, genetic information or any other protected class.

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