Analyst I, Postmarket Surveillance

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 113,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

MAIN PURPOSE OF ROLE

Summarize the main purpose of the role.

Analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.

MAIN RESPONSIBILITIES
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Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
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Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations.
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Evaluate and investigate identified complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
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Collect, compile, and document regulatory reportability decisions using event investigation and regulatory decision models.
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Draft Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
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Apply codes to events to facilitate product performance records.
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Review coding and investigations with engineering, laboratory, and other internal staff.
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Draft written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers.
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Communications include determination/eligibility for warranty credit or unreimbursed medical payments.
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Begins establishing and cultivating a network of internal resources to facilitate completion of tasks.
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Individual influence is typically exerted at the peer level.
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Completes daily work to meet established schedule with guidance from supervisor on prioritization of tasks.
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May exercise authority within pre-established limits and approval.
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Failure to achieve results can normally be overcome without serious effect on the business.

QUALIFICATIONS

Education

Education Level

Major/Field of Study

Or

Education Level

Bachelors Degree (± 16 years)

Related field

☒

an equivalent combination of education and work experience

Experience/Background

Experience

Experience Details

Some

0-2 years of related work experience with a basic understanding of specified functional area.

General knowledge and basic application of business concepts, procedures and practices.

Will perform this job in a quality system environment.

Failure to adequately perform tasks can result in noncompliance with governmental regulations.

Learns to use professional concepts and company policies and procedures to solve routine problems.

Works on problems of limited scope.

Minimal independent decision making.

JOB FAMILY:
Operations Quality

DIVISION:
HF Heart Failure

LOCATION:
United States > Massachusetts > Burlington : 168 Middlesex Turnpike

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 5 % of the Time

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf