Regulatory Affairs

Job Description

Title : Product Surveillance Analyst

Location : St. Paul, MN 55117

Duration : 11 Months

Shift : 8AM to 5PM

Description :

Under the direction of management, the Product Performance Analyst may perform two different functions. The first consists of managing product experience investigations and all activities pertaining to product experiences for Client. This includes, but is not limited to : receiving and investigating reports of worldwide product experiences / events on a variety of products, entering information into the complaint database, participating in cross-functional projects, facilitating investigation findings of product issues, assist with internal and external audits, and providing comprehensive reports, analysis, and insights on product experiences, and may extract data from the complaint database to various teams (e.g. Regulatory, Quality Engineering).

The other role of the Product Performance Analyst I is to perform evaluations of returned products, coordinating product testing / analysis with other departments and external consultants, preparing technical reports of findings, operating and maintaining the Product Performance Laboratory and equipment, and collecting and evaluating analysis data and entering it into the complaint database.

The Product Performance Analyst I may assist in the trending of complaint data as requested by management, including preparation of trending charts utilizing the complaint database and other programs, in support of the department.

Main Responsibilities :

• 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.
• 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.