Abbott Regulatory Affairs Specialist in Longford, Ireland
Abbott in Ireland
In Ireland, Abbott employs almost 3,000 people across 11 sites. Abbott has six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third party manufacturing management operation in Sligo. It has commercial and support operations in Dublin and shared services in Dublin and Westport. Abbott serves the Irish market with a diverse range of health care products including diagnostics, medical devices, nutritionals and branded generic pharmaceuticals. Abbott has been operating in Ireland since 1946.
Abbott Diagnostics Division (ADD) Longford
Abbott established the first diagnostics manufacturing facility in Sligo in 1994 to manufacture blood-screening products and reagents. In 2004, Abbott Diagnostics operations in Ireland expanded with the opening of a second facility in Longford. The plant was first occupied in December 2004. Manufacturing commenced in March of the following year 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.
We currently have a vacancy for a Regulatory Affairs Specialist and this role will involve the following:
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 & Experience
You will have 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 http://www.abbott.ie/ or http://www.abbott.com/ and connect with us on Twitter at @AbbottNews.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org