Senior Product Analyst

About the role The Senior Product Analyst analyzes customer complaints to determine regulatory reportability and coordinates activities with internal teams, field representatives and end‑use customers. This role is responsible for adherence to Good Manufacturing Practices (GMPs), complaint handling requirements under the Code of Federal Regulations (CFR), and applicable international regulations. The Senior Product Analyst communicates event investigation results through regulatory reports and written communications, as appropriate. Your responsibilities will include: Review complaint communications and assess regulatory compliance, reportability, and potential impact on patient safety and business operations. Apply clinical knowledge 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 findings and regulatory decision models. Participate in the development and modification of regulatory decision models to support product advancements and therapies while maintaining compliance with domestic and international regulations. Author Medical Device Reports (MDRs), MedWatch reports, vigilance reports and other regulatory submissions, ensuring timely transmission to appropriate regulatory authorities. Apply event coding to support product performance records and review coding and investigations with engineering, laboratory and other internal teams. Compose written communications detailing clinical observations, investigations, product analyses and corrective actions, as applicable, for physicians and other end‑use customers. Review complaint investigations and approve complaints for closure. Qualifications Required qualifications Bachelor’s degree required and a minimum of 3 years' experience, or master’s degree and a minimum of 2 years' experience. Hands‑on experience in medical device complaint handling. Familiarity with medical device terminology, as well as anatomical and physiological terminology. Ability to work independently with limited guidance and direction. Self‑motivated, goal‑driven and results‑oriented mindset. Preferred qualifications Previous experience supporting audits and inspections. Previous experience with Medical Device Reports (MDRs). Experience writing and filing MedWatch and vigilance reports. Excellent written and verbal communication skills. Strong proficiency with Microsoft Office applications, including Excel, Word and Outlook. Experience with PowerPoint, Microsoft Access, complaint database applications such as GCMS, or similar systems. Compensation Minimum Salary: $75,100. Maximum Salary: $142,600. The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see – will vary based on the actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non‑exempt (hourly), non‑sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non‑sales roles may also include variable compensation, i.e., annual bonus target and long‑term incentives (subject to plan eligibility and other requirements). Legal and Compliance Information For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. Boston Scientific continues to comply with all applicable state and federal law and healthcare credentialing requirements regarding COVID‑19 vaccination status. Certain US‑based positions, including 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. 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 maintains specific prohibited substance test requirements for safety‑sensitive positions. This role is deemed safety‑sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law. EEO Statement 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 status, age, mental or physical disability, genetic information or any other protected class. Nearest Major Market San Diego Job Segment Compliance, Medical Device, Product Manager, Law, Laboratory, Legal, Healthcare, Operations, Science #J-18808-Ljbffr Boston Scientific Gruppe