About Us
Abbott serves the Irish market with a diverse range of healthcare products, including diagnostics, medical devices, and nutritional products.
Our Presence in Ireland
We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, Longford, Sligo and a third-party manufacturing management operation in Sligo.
A World Leader in Vascular Care
Abbott Vascular is one of the world's leading vascular care businesses, focused on advancing the treatment of vascular disease and improving patient care.
Vessel Diseases
These vessel diseases can lead to heart attack, stroke, critical limb ischemia and other serious vascular conditions.
Purpose of the Job
Regulatory Operations Specialist
The Regulatory Operations Specialist is responsible for activities which lead to, and maintain, regulatory approval to market devices.
Major Responsibilities
* Develop strategies for regulatory approval of medical devices.
* Coordinate submission activities for various device regulatory approvals.
* Serve as internal consultant on regulatory issues.
* Sustain and maintain Clonmel as the Legal Entity with responsibility for specified products.
* Review and/or approve Product Release Authorization Requests.
* Facilitate and participate in inspection readiness, execution and post-inspection activities.
* Develop and deliver presentations to global regulatory agencies.
* Research regulatory requirements for assigned geographies.
* Participate in training and mentoring of staff.
Education & Competencies
* National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline.
* Working knowledge and application of business concepts, procedures and practices.
* Cultivates a wide range of internal networks and begins to develop an external network of resources.
* Plans, organizes and prioritizes own daily work routine to meet established schedule.
* Exercises authority and judgment within defined limits to determine appropriate action.