Actalent - Minnetonka, MN
posted 2 months ago
The Product Surveillance Analyst II position at Actalent involves performing electronic record management functions and regulatory reporting within the complaint handling process for a leading medical device company. The analyst will be responsible for managing complaint investigations, which includes all activities related to receiving and investigating reports of worldwide product events concerning specific medical devices. This role requires the analyst to enter information into a database and independently determine and file appropriate medical device reports with various regulatory agencies. The current project entails handling a high volume of record intake, necessitating the individual to submit numerous electronic regulatory reports for similar product events. Reports will originate from external clients and sales representatives. For instance, if a product event occurs with a device and it is reported that a doctor intends to proactively explant that device, the analyst will be tasked with completing the templated form for submission to the relevant reporting body in that specific country. This group supports the CRM business unit, which includes products such as pacemakers, leads, and implanted cardiac monitors. The role demands effective communication with all levels of employees, customers, and contractors, ensuring that all necessary information is accurately reported and documented. The position requires a strong ability to work in a fast-paced and sometimes stressful environment due to the urgent nature of the workload. The analyst must be proficient in navigating computer systems and possess strong problem-solving skills, as well as experience in writing and documenting investigations and medical device reporting.