Quality Professional – Post Market Surveillance

Job description

JOB DESCRIPTION:

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.

Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 5,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for the treatment and management of diseases and other conditions. IDEM is an over a billion-dollar business unit that now support significant growth for Abbott in COVID-19 related products in over 70+ countries

Job Description Summary:

This Quality Professional position is focused on supporting the implementation & maintenance of ADRx’s post-market surveillance reporting to meet the requirements for the In-Vitro Diagnostics Regulation (IVDR) into ARDx’s Quality System. Additionally, the Principal Quality Professional for post-market surveillance reporting leads activities assigned to them, collating needed inputs for reporting, working collaboratively with a broad cross-functional team.

Main Responsibilities:

·  Supports the implementation and maintenance of the effectiveness of the Quality System with respect to collation of data and generation of reports required to support post market surveillance reporting submissions, as assigned.
·  Works collaboratively with a global cross-functional team to revise existing or establish new quality system requirements/processes, procedures and report templates compliant with the new regulation with respect to post-market surveillance reporting.
·  Uses critical thinking to provide solutions that are compliant, innovative and consistent with organizational objectives.
·  Coordinates and leads the assigned schedule associated with the accrual, assembly of post-market surveillance inputs ensuring accurate and timely submission. Supports the processes for acquiring, managing, analyzing, interpreting and reporting Post Market Surveillance data necessary to support PMS Reports such as Periodic Safety Update Report (PSUR), Post Market Performance Follow-Up (PMPF), Post Market Clinical Follow-up (PMCF), Clinical Evaluation Report (CER) and related reports along with supporting the maintenance of appropriate Design History File (DHF) documents such as Risk Management Files (RMF).
·  Partners with Vigilance, Regulatory Affairs, Clinical Affairs, product, instrument and software teams, Field Assurance, Marketing and manufacturing facilities to proactively plan for and complete PMS reports, ensuring needed data is gathered accordingly.
·  Elevates and articulates concerns to management in a timely manner, proposing solutions and leading change as needed.
·  As a post-market surveillance reporting subject matter experts, supports audits and additional information request inquiries relating to post-market surveillance reporting.

Scope:

·  Receives general direction and exercises considerable discretion to work own detail. Recommends possible solutions.
·  Ensures compliant documentation; carrying out tasks relating to area of responsibility with management oversight.

Education:

·  Bachelor’s degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.

Experience:

·  At least 3 year’s work experience in a related field experience; less experience may be appropriate with advance degree.
·  Preferred experience in the Healthcare industry.
·  Has a history of completing successful projects and driving positive compliance outcomes.

     

The base pay for this position is
N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

IDEM ARDx Infectious Disease Emerging Markets

        

LOCATION:

Ireland > Galway : Parkmore East Business Park

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Ie - 37.5Hst0 (Ireland)

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable