Analyst I Postmarket Surveillance

3205 St. Jude Medical, Cardiology Division, I; Plano (TX); Presencial; USD 51.000 - 101.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

HIP PPO

Retirement plan

Tuition reimbursement

FreeU education

Diversity awards

Descripción de la vacante

Abbott in Plano, TX is seeking an Analyst I Postmarket Surveillance to support complaint handling, medical device reporting, and cross-functional investigations across global markets. You will enter data, prepare reports, and coordinate regulatory submissions.

The role requires strong communication, independent work skills, and the ability to collaborate with Quality, R&D, and Legal to ensure compliant processes and timely communications. Training and career growth opportunities are available.

Formación

• Strong written and oral communication skills required.
• Ability to work independently and on teams in a busy department.
• Knowledge of global regulations for medical device reporting is a plus.

Responsabilidades

• Investigate and manage product complaints across global markets.
• Enter and maintain complaint data in the database.
• Prepare technical reports and regulatory submissions (FDA, EU) as needed.
• Collaborate with cross-functional teams (QEs, R&D) on evaluation trends.
• Support inspections by regulatory agencies.

Conocimientos

Strong written and oral communication

Problem solving

Attention to detail

Team collaboration

Educación

Bachelor’s degree in healthcare or science

2-year degree with relevant experience

Herramientas

Computer skills

Descripción del empleo

Job Title

Analyst I Postmarket Surveillance

Location

Plano, TX - Neuromodulation Division, Abbott

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

Job Description

Under the direction of the department manager, the Postmarket Surveillance Analyst I may perform two different functions within the complaint handling. One role would be that of complaint investigation management and includes all activities pertaining to product complaints for Abbott. This includes, but is not limited to: receiving and investigating reports of worldwide complaints/events on a variety of products; entering information into the complaint database; independently determining and filing appropriate medical devices reports with various regulatory agencies; participating on cross-functional teams; and providing information on product complaints, including data extracted from the complaint database to various teams (e.g. Regulatory, Quality Engineering). What You’ll Work On Communicates verbally and in writing both internally and externally to SJM regarding information needed specific to new product complaints (e.g. physicians, hospital personnel, sales representatives, international offices), initiates and manages the complaint file Investigates complaints/events in a timely manner. Maintains accurate entry of complaints in database. Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities) and sends reports within required timeframes. Prepares customer letters with findings. Records condition of returned products including observations, photographs. Coordinates product testing/analysis with other departments and external consultants. Prepares technical reports of analysis/findings--Tracks returned products within the database, as appropriate; Works collaboratively with cross-functional groups (e.g. QEs, R&D) on evaluation trends or findings; Interprets technical product specifications, Device History Records, or measurements obtained; and Utilizes safe bio-hazard and chemical handling practices at all times. Duties associated with either role: Is diligent of any unusual trends in product complaints; Participates 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 meetings); Archives complaint records or returned products & retrieves information on previous investigations; Supports complaint database upgrades and conversions by providing input and performing system testing; Ensures accurate department procedures and work instructions are maintained; and support inspections by regulatory agencies (e.g. FDA, TUV) as requested. The Product Surveillance Analyst must be able to: Collaborate independently with other team members and departments needing product complaint information; Be able to conduct investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints; Be able to make sound decisions regarding medical device reporting to various global regulatory agencies, minimizing the need for input from department management; Use procedures, judgment and experience to determine appropriate testing of returned products with minimal guidance; and be able to ascertain when additional support may be needed from other teams based on product analysis findings (e.g. potential manufacturing-related issues) Train others in Product Surveillance product complaint handling. Provide support to Legal Dept on product complaints. Support all Divisional initiatives as identified by divisional management and in support of 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. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities, on occasion, as assigned. 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. Activities require a significant amount of sitting in front of a computer monitor, some standing and walking. Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment. Performs tasks that regularly require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees.

Required Qualifications

• Bachelors Degree preferably in the healthcare or science fields; or 2-year degree and relevant experience supporting complaint handling investigations, medical device reporting, or product analysis.
• Degreed applicants without medical, scientific, or complaint handling experience may be considered if they possess the strengths suitable for this position or an equivalent combination of education and work experience.
• Knowledge of global regulations for medical device reporting and medical terminology is a plus.
• Strong written and oral communication skills are required.
• Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously.
• Good problem-solving and proficient computer skills are required.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to maintain regular and predictable attendance.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

The base pay for this position is $50,700.00 – $101,300.00 In specific locations, the pay range may vary from the range posted.

Job Family

Operations Quality

Division

NM Neuromodulation

Location Details

United States > Texas > Plano : 6600 Pinecrest

Work Shift

Standard

Travel

Not specified

Medical Surveillance

Not Applicable

Significant Work Activities

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)

Company Overview

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, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Company Culture

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

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