Postmarket Surveillance Analyst II

Title: Postmarket Surveillance Analyst II

Location: Plano, TX 

Duration: 12 Month Assignment (100% onsite)

Position Overview:

We are seeking a detail-oriented and highly motivated Postmarket Surveillance Analyst II to join our team in Plano, TX. This role is responsible for managing and maintaining complaint files, assessing adverse event reports, and ensuring compliance with regulatory reporting requirements, including those of the FDA and other global agencies. The ideal candidate will have a strong background in customer service or healthcare, excellent communication skills, and the ability to work independently within a regulated environment.

Key Responsibilities:

• Initiate, manage, and maintain complaint files and ensure accurate data entry into complaint databases
• Communicate with field representatives (e.g., physicians, hospital personnel, sales reps) to obtain information specific to product complaints
• Independently evaluate complaints to determine if medical device reports (MDRs) are required by regulatory bodies (e.g., FDA, ECA)
• Submit MDRs and other required reports within regulatory timelines
• Monitor trends in complaint data and escalate issues to management as needed
• Ensure compliance with FDA regulations, global regulatory requirements, and internal company policies and SOPs
• Maintain effective and professional communication with internal teams, customers, and contractors
• Perform additional duties and responsibilities as assigned

Qualifications:

• Bachelor’s degree in Biomedical Engineering, Life Sciences, Nursing, or a related discipline required
• Will consider fresh graduates or candidates with an associate degree and 3 years of relevant undergraduate coursework
• Candidates with clinical backgrounds such as Lab Technicians, LVNs, or Nurses are strongly encouraged to apply
• Master's or PhD candidates may be considered overqualified
• 1 year of experience in customer service, complaint handling, or a quality/compliance environment preferred
• Knowledge of Class III medical devices is a plus

Skills & Competencies:

• Strong written and verbal communication skills, with the ability to communicate across all organizational levels
• Excellent time management and organizational abilities
• Proficiency in Microsoft Office Suite (especially Excel) and SAP
• Strong attention to detail, self-motivated, and able to work independently

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.