Offers “Abbott”

Expires soon Abbott

Manager Regulatory Affairs

  • Internship
  • IRELAND

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).

The primary responsibility of the Manager Regulatory Affairs includes;

· 
Lead the Regulatory Affairs function at the site

· 
Provide Regulatory support and leadership to the site ensuring compliance with global regulatory requirements & Abbott Quality System regulations.

MAJOR RESPONSIBILITIES

· 
Provide leadership to the site in the area of Regulatory Affairs.

· 
Ensure regulatory and compliance requirements are met for both current base business and project-related activities.         

· 
Execute and complete tasks and deliverables for CE marking activities as required according to IVD Directive.

· 
Provide update and maintain status of product registrations and notifications.

· 
Provide documentation to Area Regulatory Affairs for product registrations and notifications outside the European Union.

· 
Coordinate vigilance and post market surveillance activities.

· 
Communication with Competent Authorities and Notified Bodies

· 
Regulatory input during the design phase of new products

· 
Creation, Maintenance and change control of Technical Documentation for site products.

· 
Conduct regulatory sign-off for site products

· 
Create notifications of changes and submit to the Notified Body where applicable.

· 
Conduct Notified Body Assessments for new Annex II products

· 
Preparation of legal documents for commercial affiliates

· 
Maintain ETMS TO DO LIST.

· 
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.

EDUCATION & COMPETENCIES:

· 
The following level of education provides a necessary foundation for this Job function:

· 
Third level qualification in relevant discipline - Science, Life Sciences, Engineering etc.

· 
Minimum of 5 years industry - relevant experience in the diagnostic or a related industry is desirable

· 
Excellent communication skills desired. Communicates with co-workers, other departments, other sites and external regulatory agencies.

· 
A Minimum of 2 years of people management experience is preferable.

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.

#IJ_1

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

ADD Diagnostics

        

LOCATION:

Ireland > Longford : Lisnamuck

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Ie - Shftpre0 (Ireland)

     

TRAVEL:

Yes, 25 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

     

     

     

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