**Abbott in Ireland** Abbott 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. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, 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 Ireland Vascular Division Clonmel** Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development and advancing medicine through training and education. Our broad line of vascular devices–which includes vessel closure, endovascular and coronary technologies–are used to treat vessel diseases of the heart, carotid arteries and peripheral blood vessels. These vessel diseases can lead to heart attack, stroke, critical limb ischemia and other serious vascular conditions. **PURPOSE OF THE JOB** The Regulatory Operations Specialist is responsible for activities which lead to, Statement and maintain regulatory approval to market devices. Additionally, the Specialist is responsible for assessment of device changes for regulatory implications. **MAJOR RESPONSIBILITIES** 1.Develop strategies for regulatory approval of medical devices. 2. Coordinate submission activities for a variety of device regulatory approvals including: United States pre-market approvals, international design dossiers, post-approval reports, export certificates, clinical trial exemptions and establishment registrations and listings. 3. Serve as 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 / or Approve Product Release Authorization Requests. 6. Facilitate and participate in inspection readiness, execution and post inspection activities. Interacts cross functionally and with internal and external customers to complete tasks. 7. Develop and deliver presentations to global regulatory agencies. Topics may include submission strategies/ 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+ years of related work experience, or an equivalent combination of education and work experience. 2. Working knowledge and application of business concepts, procedures and practices. Will be performing this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. 3. Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Must have a general knowledge of technical alternatives and an understanding of their impact on the systems environment. 4. Cultivates a wide range of internal networks and begins to develop an external network of resources to facilitate completion of tasks. May demonstrate basic project management skills by acting as a project lead on small, well defined projects. Provides guidance to less experienced staff. Influence exerted at peer level and occasionally at first levels of management. 5. Plans, organises and prioritises own daily work routine to meet established schedule. 6. Exercises authority and judgment within defined limits to determine appropriate action. Failure to achieve results or erroneous decisions or recommendations may cause delays and may result in the allocation of additional resources. 7. Works under general supervision. Receives limited supervision on standard issues and detailed instructions on new assignments. Work is reviewed for soundness of judgment, overall adequacy and accuracy. 8. May provide limited work direction and guidance to exempt and/or skilled nonexempt levels of employees. May be asked to evaluate performance of and assist in career development planning for subordinates. **REFER TO THE SITE SAFETY STATEMENT (SHE038447) FOR YOUR SAFETY, HEALTH AND WELFARE AT WORK RESPONSIBILITIES** **Abbott Ireland is an Equal Opportunities Employer** Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. 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