Abbott in Ireland serves the Irish market with a diverse range of healthcare products, including diagnostics, medical devices, and nutritional products. In Ireland, Abbott employs over 6,000 people across ten sites. The company has seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, Longford, and Sligo, as well as a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations, and shared services in Dublin and Galway.
The company has been operating in Ireland since 1946. Abbott Vascular is one of the world's leading vascular care businesses, focused on advancing the treatment of vascular disease and improving patient care through medical device innovations and pharmaceuticals.
The Regulatory Operations Specialist is responsible for activities leading to statement and maintenance of regulatory approval to market devices. Additionally, the specialist assesses device changes for regulatory implications.
Major Responsibilities
1. Develop strategies for regulatory approval of medical devices.
2. Coordinate submission activities for various device regulatory approvals, including US pre-market approvals, international design dossiers, post-approval reports, export certificates, clinical trial exemptions, and establishment registrations and listings.
3. Serve as an internal consultant on regulatory issues, such as submissions, recalls, advertising, and promotional activities, field actions, or review of proposed device changes.
4. Sustain and maintain Clonmel as the legal entity with responsibility for specified products.
5. Review and approve product release authorization requests.
6. Facilitate and participate in inspection readiness, execution, and post-inspection activities, interacting with internal and external customers.
7. Develop and deliver presentations to global regulatory agencies on topics such as submission strategies and compliance issues.
8. Research regulatory requirements for assigned geographies, monitor emerging trends, and integrate new requirements into department procedures and toolkits.
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 an equivalent combination of education and work experience.
3. Working knowledge and application of business concepts, procedures, and practices.
4. Cultivates a wide range of internal networks and begins to develop an external network of resources to facilitate completion of tasks.
5. Plans, organizes, and prioritizes own daily work routine to meet established schedule.
6. Exercises authority and judgment within defined limits to determine appropriate action.
7. Works under general supervision.
8. May provide limited work direction and guidance to exempt and/or skilled nonexempt levels of employees.
Estimated salary: €50,000 - €70,000 per year, depending on qualifications and experience.