Analyst, Product Surveillance

Abbott; Saint Paul (MN); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

Medical Plan

Dental Plan

Vision Plan

Health Savings Account

Flexible Spending Accounts

Supplemental Life Insurance

Short Term Disability

Long Term Disability

401(k)

Job summary

Abbott is seeking an Analyst, Product Surveillance in Saint Paul, MN, onsite for a 12-month contract-to-hire. The role analyzes and submits complaints and investigates returned products from the field, including biohazard scenarios used in surgery.

A science background and strong organizational skills are essential. Responsibilities include managing product experience files, communicating with physicians and hospital staff, and supporting FDA/regulatory inspections.

Qualifications

• 4-year science degree required in bio, chemistry or life sciences.
• Experience with complaint handling or product investigations is a plus.
• Strong organization and priority setting essential.
• Effective cross-functional communication with internal and external stakeholders.

Responsibilities

• Initiates and manages the product experience file and triages new reports.
• Communicates information needed for product experiences with physicians, hospitals, and sales teams.
• Maintains collaboration across QEs, R&D, medical affairs, and other teams.
• Assesses product experience to determine if a medical device report is needed.
• Assesses complaints to determine escalation needs and supports regulatory inspections.
• Ensures procedures are up to date and supports regulatory requirements.

Skills

Science degree background

Complaint handling

Investigation skills

Cross functional communication

Education

4-year degree in science

Job description

Title: Analyst, Product Surveillance
Location: One St Jude Medical Drive, St. Paul, MN
Duration: 12 Months, contract to hire
100% Onsite
This 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 have
• Highly organized – able to prioritize well
• Cross functional communication

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.
• 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 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)

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.