Regulatory Affairs Specialist

Job description

     

JOB DESCRIPTION:

Job Description

About Abbott

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 107,000 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 4,000 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 Ireland Diagnostic Division – Longford:
Abbott established a diagnostics manufacturing facility in Sligo in 1994 to manufacture blood-screening products and reagents.

In 2004, Abbott’s operations in Ireland expanded with the opening of a second facility in Longford. The plant was first occupied in December 2004, and the first product (Architect® TSH) was launched in December of 2005.

The Longford facility plays a key role in helping Abbott to meet the increasing global demand for diagnostic testing in areas such as infectious disease, cancer, thyroid and cardiovascular diseases.

Abbott in Longford manufactures 18 diagnostic reagent products for thyroid function, fertility, and pregnancy, cardiology, renal and metabolic. Our products are manufactured to the highest standards of quality and are regulated by bodies such as the U.S. Food and Drug Administration and the International Organization for Standardization (ISO).

MAJOR RESPONSIBILITIES

·  Provide support for Regulatory Affairs related issues to ensure compliance with global regulatory requirements & Abbott Quality System regulations.
·  Execute and complete tasks and deliverables for CE marking activities as required according to IVD Directive.
·  Prepare and maintain Technical Documentation for Irish manufactured products.
·  Provide update and maintain status of product registrations and notifications.
·  Provide the required information including legal documentation for country specific Regulatory Affairs contacts to enable and maintain product submissions outside the EU as required.
·  Provide, as required, regulatory input and approval for changes and classification of changes to Device Master Records, Quality System records, labelling etc.
·  Perform regulatory risk assessments and provide approval for Customer and Quality Technical Communications.
·  Conduct business in a manner that will protect human health, safety and the environment by complying with all applicable EHS laws, as well as the Abbott Global & Technical Standards.
·  Maintain ETMS To Do training list including those standards, Directives, and Regulations defined as relevant.

EDUCATION & COMPETENCIES:

·  A relevant third level qualification to Degree level with 2-3 years experience in Regulatory, Technical or Quality areas within the devices or pharmaceutical industry,
·  Advanced organizational skills and attention to detail.
·  The ability to work co-operatively and effectively with others to establish and maintain good working relationships.
·  The highest levels of integrity in the successful completion of your work.
·  Excellent Communication Skills

Visit Abbott at https://www.ie.abbott/ and connect with us on Twitter at @AbbottNews.

Connect with us at  www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at  www.facebook.com/Abbott  and on Twitter @AbbottNews and @AbbottGlobal.

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JOB FAMILY:

Regulatory Operations

     

DIVISION:

ADD Diagnostics

        

LOCATION:

Ireland > Longford : Lisnamuck

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Ie - Shftpre0 (Ireland)

     

TRAVEL:

Yes, 10 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable