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Abbott Senior Regulatory Affairs Specialist in Galway, Ireland

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 109,000 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 Rapid Diagnostics 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 the treatment and management of diseases and other conditions. IDEM is an over a billion-dollar business unit that now support significate growth for Abbott in COVID-19 related products in over 70+ countries.

The RA Manager: Works as part of the Regulatory Affairs department with direct responsibility for developing regulatory plans with high level of complexity. Plans and prepares documentation for international and domestic product registrations for new and modified products. Interacts with governmental regulatory agencies, other third party accrediting bodies, and US trade associations. This role would not have an immediate team to manage however as the role grows, this would be reviewed.

This job description will be reviewed periodically and is subject to change by management.

RESPONSIBILITIES:

  • Provides regulatory support for diagnostic product development and commercial diagnostic products

  • Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the US and internationally

  • Researches scientific and regulatory information in order to write, edit, and review submission documents

  • Compiles and publishes all material required for submissions, license renewals, and annual registrations

  • Works with governmental regulatory agencies and other third party accrediting bodies

  • Maintains approvals/licenses/authorizations for existing marketing authorizations

  • Ensures accuracy of US registration and device listing

  • Adds and maintains information contained in the Global Regulatory Information Database

  • Provides recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance

  • Reviews validation reports for regulatory submission soundness

  • Assesses product, manufacturing and labeling changes for regulatory reporting impact and compliance to regulations

  • Reviews advertising and promotion to ensure compliance with product claims

  • Keeps informed of global regulatory information; prepares impact assessments

  • Represents Abbott on US trade associations and contributes to trade positions

  • Develops internal procedures and tools

  • Conducts informational or training sessions for stakeholders

  • Organizes and maintains hard copy and electronic department files

  • Contributes to management review for new or revised regulations and/or other quality system activities

  • Assists with hosting inspections, as needed

  • Assists with conducting internal/external audits, as needed

  • Assists with resource planning and budgeting, as needed

  • Carries out duties in compliance with established business policies

  • Demonstrates commitment to the development, implementation and effectiveness of Abbott Quality Management System 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

  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities

  • Other duties as assigned, according to the changing needs of the business

MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:

  • Bachelor's degree (BS/BA) in any scientific field.

  • 3-5 years experience experience in Regulatory Affairs within a Senior Specialist role.

  • Management experience would be highly advantageous

  • Strong knowledge of federal and international regulations

  • Strong knowledge of quality systems in a regulated manufacturing environment

  • Demonstrated written and verbal communication skills

  • Ability to work on multiple projects simultaneously

  • Possess a high degree of accuracy and attention to detail

PREFERRED QUALIFICATIONS:

  • Five plus years in an IVD or medical device manufacturing environment

  • Good knowledge of business models, resource planning and budgeting

  • Supervisor experience preferred

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Connect with us at www.abbott.com or https://www.ie.abbott/ , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews (https://twitter.com/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 corpjat@abbott.com

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