Abbott Senior Regulatory Affairs Specialist in Galway, Ireland
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.
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
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 email@example.com