Product Surveillance Analyst II - Big 3 Medical Device Company

Actalent - Minnetonka, MN

Full-time - Mid Level

Minnetonka, MN

10,001+ employees

Administrative and Support Services

About the position

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.

Responsibilities

• Perform electronic record management functions and regulatory reporting within complaint handling.
• Manage complaint investigations related to worldwide product events for specific medical devices.
• Enter information into the database accurately and efficiently.
• Independently determine and file appropriate medical device reports with various regulatory agencies.
• Handle high volume record intake and submit numerous electronic regulatory reports for similar product events.
• Complete templated forms for reporting product events to the relevant bodies in various countries.
• Communicate effectively with employees, customers, and contractors regarding product events and reporting requirements.

Requirements

• Bachelor's Degree in a science-related field.
• 2+ years of experience in post-market surveillance, medical device, or pharmaceutical industry.
• Proven ability to communicate effectively and efficiently, as verified by references.
• Strong problem-solving skills, as verified by references.
• Proficient at navigating computer systems, as verified by references.
• Experience in investigations, medical device reporting, or product evaluation.
• Writing experience related to regulatory reporting.

Nice-to-haves

• Previous knowledge of global regulations for medical device reporting.
• Knowledge of medical terminology.
• Experience juggling multiple responsibilities, such as working while attending school or participating in sports.
• Previous experience in OUS regulatory reporting or MDR.