Analyst, Product Surveillance

Location: One St Jude Medical Drive, St. Paul, MN

Duration: 12 Months, contract to hire, 100% Onsite

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.
• 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.
• Provides support to Legal Department regarding product complaints.
• Works collaboratively with cross-functional groups (e.g. QEs, R&D, medical affairs, medical education, etc.).
• 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.
• 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.

Qualifications

• 4-year degree science background; bio, chem, life sciences, etc.
• Complaint handling, investigation of product performance experience nice to have

Skills

• Highly organized – able to prioritize well
• Cross functional communication

Benefits

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)