Product Complaint Analyst I

Product Complaint Analyst I

The Product Complaint Analyst I will work in a fast-paced environment to analyze customer complaints for the Urology Complaint Management Center (CMC) to determine which are regulatory reportable. Will be responsible for adherence to Good Documentation Practices (GDP) and required processing of complaint handling records per the Code of Federal Regulations (21CFR) and International regulatory agencies. In addition, will initiate follow up with field sales representatives, end use customers and complaint investigation site to obtained additional event details, as applicable. Communicates event investigation results via regulatory reports and written communications, as appropriate. Products within scope include but are not limited to men's prosthetic urology, prostate health, and surgical lasers.

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: dispositioning of events that meet complaint criteria, accurately performing regulatory assessment, filing regulatory reports within country respective timelines, following up with customer, physician and sales representative for additional information as applicable, coordinating and collaborating with the complaint investigation site for on time completion of event investigations in order to meet regulatory report filing due dates, issuing customer response letters, closing complaint files and documenting objective evidence for audit readiness, following implemented policies and procedures to ensure compliance with appropriate statues and regulations, and participating in department system improvement projects while able to manage assigned work to achieve Urology monthly metric objectives.

Required qualifications include a bachelor's degree, excellent time management and ability to apply critical thinking, and strong administrative skills and ability to effectively multitask in a fast-changing administrative environment.

Preferred qualifications include strong organization and execution skills required, as well as a demonstrated ability to confidently drive project completion, demonstrated ability to motivate, lead, make recommendations, and work in cross-functional teams, effectively able to multitask and prioritizes work in a fast paste changing environment, strong interpersonal, communication, presentation and writing skills, experience working within medical device industry and familiarity with 21 CFR 820, EU MDR, and ISO 13485 regulations, quality systems background key quality system regulations (21 CFR 820 and ISO 13485 at a minimum), basic understanding of complaints or complaint handling process, and proficient in Microsoft Power Point, Excel, Outlook, Microsoft Word and Teams, eMDR and EUMDR Regulatory filing experience.