Product Complaint Analyst I

Your responsibilities will include: Coordinate and collaborates with the complaint investigation site for on time completion of event investigations in order to meet regulatory report filing due dates. Participates in department system improvement projects while able to manage assigned work to achieve Urology monthly metric objectives. Bachelor's degree Minimum of 2 years of related work experience 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 Proficient in Microsoft Power Point, Excel, Outlook, Microsoft Word and Teams eMDR and EUMDR Regulatory filing experience