Analyst II, Postmarket Surveillance at Abbott

Plano, Texas, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Ability to communicate verbally and in writing both internally and externally (e.g., with physicians, hospital personnel, sales representatives, international offices)
Skills in investigating complaints/events in a timely manner
Proficiency in maintaining accurate entry of complaints in a database
Capability to independently assess complaints and determine if a medical device report needs to be filed with global regulatory agencies (e.g., FDA, European Competent Authorities), and send reports within required timeframes
Experience preparing customer letters with findings
Ability to record condition of returned products, including observations and photographs
Competence in coordinating product testing/analysis with other departments and external consultants
Skills in preparing technical reports of analysis/findings
Ability to track returned products within the database
Experience working collaboratively with cross-functional groups (e.g., Quality Engineers, R&D) on evaluation trends or findings
Proficiency in interpreting technical product specifications, Device History Records, or measurements obtained
Knowledge of safe bio-hazard and chemical handling practices
Diligence in identifying unusual trends in product complaints
Participation in cross-functional complaint review groups (e.g., cross-functional complaint teams, rapid customer response team, Risk Management)

Responsibilities

Receive and investigate reports of worldwide complaints/events on a variety of products under the direction of the department manager
Enter information into the complaint database
Independently determine and file appropriate medical device reports with various regulatory agencies
Participate on cross-functional teams
Provide information on product complaints, including data extracted from the complaint database, to various teams (e.g., Regulatory, Quality Engineering)
Initiate and manage the complaint file
Communicate verbally and in writing both internally and externally regarding information needed specific to new product complaints
Prepare customer letters with findings
Record condition of returned products including observations, photographs
Coordinate product testing/analysis with other departments and external consultants
Prepare technical reports of analysis/findings
Track returned products within the database, as appropriate
Work collaboratively with cross-functional groups (e.g., QEs, R&D) on evaluation trends or findings
Interpret technical product specifications, Device History Records, or measurements obtained
Utilize safe bio-hazard and chemical handling practices at all times
Be diligent of any unusual trends in product complaints
Participate in cross-functional complaint review groups on a regular basis or as requested (e.g., cross-functional complaint teams, rapid customer response team, Risk Management)

Skills

Postmarket Surveillance

Complaint Handling

Complaint Investigation

Medical Devices

Neuromodulation

Regulatory Compliance

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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