About Abbott

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 113,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Abbott in Ireland

Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products. In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.

Abbott Galway

Abbott in Galway serves as the international hub for Abbott's Rapid Diagnostics business, which delivers annually more than 2 billion tests. As the global leader in point-of-care diagnostics, Abbott offers the broadest portfolio of best-in-class rapid tests, services, and handheld devices across all healthcare settings: the lab, the clinic, remote healthcare outposts, retail outlets, the patient's bedside and at home. Our industry-leading near patient tests and services are unmatched across key health and therapeutic areas, including: infectious disease, cardiometabolic & informatics, toxicology and consumer diagnostics.

One of the key functions in Galway is Global Business Services, which provides number of shared services activities across finance, purchasing, quality, technical and customer services for Europe, Middle East and Africa (EMEA). Various global and EMEA commercial and operational management teams across our infectious disease and cardiometabolic businesses are also based in Galway, overseeing the supply of millions of rapid tests from HIV to diabetes to COVID-19, to patients in many regions across the world.

Position Summary

Abbott Rapid Diagnostics (ARDx) 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 treatment and management of diseases and other conditions.

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 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.

Please note this is a 12-month Fixed Term Contract

Essential Duties and Responsibilities

Carries out duties in compliance with established business policies and procedures.Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.Perform other duties and projects as assigned.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.

Basic Qualifications – Education / Experience / Skills

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

Preferred Qualifications

Demonstrated knowledge and/or understanding of Health care industry.Prior experience in Has a history of completing successful projects and driving positive compliance outcomes. 

Competencies

 At least 3 year’s work experience in a related field experience; less experience may be appropriate with advance degree.