Product Analyst II Job

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - 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 this role: The Maple Grove Complaints Handling Team has developed a model for efficiently and compliantly processing complaints that has led to an admirable record of results. The management approach is based on a team centered model where each employee has a voice in how we operate and optimize current processes. This position is in a supportive environment of providing employees with opportunities to learn and enhance skill sets that are aligned with future career direction. The Product Analyst II analyzes customer complaints 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 complaint handling per the Code of Federal Register (CFR) and all other international 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 regulator decision models with changes in product advances/therapies to uphold consistent compliance with government mandated regulations (domestic & international). • Author Medical Device Reports (MDRs), Med Watch, 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 in you: Minimum Qualifications • Bachelor s Degree Required and 3 years of experience or Master's degree and 2 years of experience • Hands-on experience in medical device complaint handling • Familiarity with medical device terminology as well as anatomical and physiological terminology is required. • Must be self-motivated, goal-driven and results-oriented; must be able to perform with limited guidance and direction Preferred Qualifications • Excellent written and verbal communication skills • Direct experience in writing and filing Med Watch and Vigilance reports preferred • Strong proficiency in common computer applications such as Microsoft Office (Excel, Word, Outlook); experience with presentation applications such as PowerPoint and/or database applications such as Microsoft Access, and complaint database applications such as Global Complaint Management System - Track Wise, is a plus. Requisition ID: 480461 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 rewarding 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 drug-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. Estimated Salary: $20 to $28 per hour based on qualifications