Our company, Abbott, serves the Irish market with a diverse range of healthcare products, including diagnostics, medical devices, and nutritional products. We have a significant presence in Ireland, employing over 6,000 people across ten sites.
We operate seven manufacturing facilities in Clonmel, Cootehill, Donegal, Kilkenny, Longford, and Sligo, as well as a third-party manufacturing management operation in Sligo. Our commercial, support operations, and shared services are based in Dublin and Galway.
Abbott Vascular Division
Abbott Vascular is a leading global player in the vascular care business, focused on advancing the treatment of vascular disease and improving patient outcomes through innovative medical device technologies and world-class pharmaceuticals.
Our Products
* Vessel closure systems
* Endovascular technologies
* Coronary technologies
Our broad line of vascular devices helps treat vessel diseases of the heart, carotid arteries, and peripheral blood vessels, which can lead to serious conditions like heart attack, stroke, critical limb ischemia, and other vascular diseases.
Purpose of the Job
The Regulatory Operations Specialist is responsible for ensuring regulatory approval to market our medical devices. This includes assessing device changes for regulatory implications and maintaining Clonmel as the legal entity for specified products.
Main Responsibilities
1. Develop strategies for regulatory approval of medical devices
2. Coordinate submission activities for various device regulatory approvals
3. Serve as an internal consultant on regulatory issues
4. Maintain Clonmel as the legal entity for specified products
5. Review and/or approve Product Release Authorization Requests
6. Facilitate inspection readiness, execution, and post-inspection activities
7. Develop and deliver presentations to global regulatory agencies
8. Research regulatory requirements for assigned geographies
9. Participate in training and mentoring of staff
10. Participate in department development initiatives
Education & Competencies
1. National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline
2. 2+ years of related work experience or equivalent combination of education and work experience
3. Working knowledge and application of business concepts, procedures, and practices
4. Cultivates internal networks and begins to develop external networks for resource facilitation
5. Plans, organizes, and prioritizes daily work routine to meet established schedule
6. Exercises authority and judgment within defined limits
7. Works under general supervision
8. May provide limited work direction and guidance to exempt and/or skilled non-exempt levels of employees