Analyst, Product Surveillance

Summary

Title : Analyst, Product SurveillanceLocation : One St Jude Medical Drive, St. Paul, MNDuration : 12 Months, contract to hire100% OnsiteThis position will analyze and submit complaints and/or investigate returned products from the field (some biohazard as they are used in surgery).Qualifications:4-year degree science background; bio, chem, life sciences, etc.Complaint handling, investigation of product performance experience nice to haveHighly organized – able to prioritize wellCross functional communicationMain 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. 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 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.Consultants Eligible Benefits Upon Waiting Period:Medical and Prescription Drug PlansDental PlanVision PlanHealth Savings Account (for High Deductible Health Plans)Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)Supplemental Life InsuranceShort Term Disability (coverage varies by state)Long Term DisabilityCritical Illness, Hospital coverage, Accident InsuranceMetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance401(k)Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.#J-18808-Ljbffr

Job Description

Title : Analyst, Product SurveillanceLocation : One St Jude Medical Drive, St. Paul, MNDuration : 12 Months, contract to hire100% OnsiteThis position will analyze and submit complaints and/or investigate returned products from the field (some biohazard as they are used in surgery).Qualifications:4-year degree science background; bio, chem, life sciences, etc.Complaint handling, investigation of product performance experience nice to haveHighly organized – able to prioritize wellCross functional communicationMain 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. 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 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.Consultants Eligible Benefits Upon Waiting Period:Medical and Prescription Drug PlansDental PlanVision PlanHealth Savings Account (for High Deductible Health Plans)Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)Supplemental Life InsuranceShort Term Disability (coverage varies by state)Long Term DisabilityCritical Illness, Hospital coverage, Accident InsuranceMetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance401(k)Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.#J-18808-Ljbffr