Product Surveillance Analyst

Title                             : Product Surveillance Analyst
Location                      : St Paul, MN 55117

Duration                      : 5+ Months (with possibility to extension or convert to full time on client needs and performance)

Shift Timing                : 8: 00 AM – 4:00 PM

·         Initiates and manages the product experience file. Maintains accurate entry of product experiences in the database. Triages new product experience report files from time to time.

·         Investigates events in a timely manner. Uses procedures, judgment, and experience to determine appropriate testing of returned products with occasional support; can ascertain when additional support is needed from other teams based on product analysis findings (e.g. potential manufacturing-related issues). Maintains accurate entry of product experiences in database. Records condition of returned products including observations and photographs. Interprets technical product specifications, Device History Records, or measurements obtained; and always utilizes safe biohazard and chemical handling practices.

·         Communicates verbally and in writing both internally and externally regarding information needed specific to product experiences (e.g. physicians, hospital personnel, sales representatives, international offices). Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

·         Independently assesses the product experience to determine if a medical device report needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities).

·         Independently assesses the complaint to determine if an escalation is required.

·         Ensures accurate department procedures and work instructions are maintained. Supports inspections by regulatory agencies (e.g. FDA, TUV, BSI, etc.) as requested. Provide support to Legal Department regarding product complaints.

·         Works collaboratively with cross-functional groups (e.g. QEs, R&D, medical affairs, medical education, etc.). May coordinate product testing/analysis with other departments and external consultants.

·         May track returned products within the database, as appropriate.

·         Supports the Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

·         Performs other related duties and responsibilities, on occasion, as assigned.

·         Work environment varies from well lighted office/cubicle, low to moderate noise level, to a variety of conditions caused by travel requirements such as customer offices, research labs, hospitals, hotels, use of automobiles, commercial travel, weather, etc.

·         Activities require a significant amount of sitting in front of a computer monitor, with some standing and walking. Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment. Performs tasks that regularly require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees..