• Regulatory Affairs Specialist Jobs in Ireland - 25367015

  • Abbott India Ltd
  • Ireland
  • Save Job
  • 2 - 3 Years
  • Posted : above 1 month

Job Description:

About Abbott

At Abbott, were committed to helping you live your best possible life through the power of health For more than 125 years, weve 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, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve

Abbott in Ireland

In Ireland, Abbott employs more than 3,200 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 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

Discover why candidates choose a career at Abbott Ireland here

We currently have a vacancy for a Regulatory Affairs Specialist and this role will involve the following

Key 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 & 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

Key Skills

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

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare, Manufacturing/Industrial
Functional Area : IT Software : Software Products & Services
Role : Software Engineer
Salary : As per Industry Standards
Deadline : 09th Jun 2020

Key Skills:

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