Analyst II, Post Market Surveillance at Abbott

Burlington, Massachusetts, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Experience and knowledge of products and various types of product complaints
Ability to independently perform investigations with minimal direction
Ability to independently assess complaints to determine if medical device reports need to be filed with global regulatory agencies (e.g., FDA, European Competent Authorities)
Knowledge of U.S. Food and Drug Administration (FDA) regulations and other regulatory requirements

Responsibilities

Initiates and manages the complaint file and maintains accurate entry of complaints in the database
Communicates verbally and in writing internally and externally (e.g., with physicians, hospital personnel, sales representatives, international offices) regarding product complaints
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Performs investigations with customers or field staff independently
Determines and files appropriate medical device reports with various global regulatory agencies within required timeframes
Prepares customer letters with investigation findings
Monitors for unusual trends in product complaints and communicates them to management
Participates in cross-functional complaint review groups (e.g., complaint teams, new product teams, risk management meetings)
Archives complaint records and retrieves information on closed investigations
Ensures accurate department procedures and work instructions are maintained
Trains new employees to the complaint handling process
Provides support to the Legal Department regarding product complaints
Supports the Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Complies with FDA regulations, other regulatory requirements, company policies, operating procedures, and processes

Skills

Post Market Surveillance

Complaint Investigation

Regulatory Reporting

Medical Devices

Complaint Database

Heart Failure Devices

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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