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 assess complaints and determine if medical device reports need to be filed with global regulatory agencies (e.g., FDA, European Competent Authorities)
Strong verbal and written communication skills for internal and external interactions
Positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors
Ability to work independently with minimal direction
Diligence in identifying and communicating unusual trends in product complaints
Participation in cross-functional teams and meetings
Compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, and processes
Support for Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

Responsibilities

Initiate and manage the complaint file; maintain accurate entry of complaints in the database
Communicate verbally and in writing internally and externally (e.g., with physicians, hospital personnel, sales representatives, international offices) regarding product complaints
Independently perform investigations with customers or field staff
Independently determine and file appropriate medical device reports with various global regulatory agencies within required timeframes, consulting management as needed
Prepare customer letters with investigation findings
Monitor and communicate unusual trends in product complaints to management
Participate in cross-functional complaint review groups (e.g., complaint teams, new product teams, risk management meetings)
Archive complaint records and retrieve information on closed investigations
Ensure accurate department procedures and work instructions are maintained
Train new employees on the complaint handling process
Provide support to the Legal Department regarding product complaints
Perform other related duties and responsibilities as assigned

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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