Job Description
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 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.
Broad Line of Vascular Devices
We have a broad line of vascular devices which includes vessel closure, endovascular and coronary technologies. These devices 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, and maintain, regulatory approval to market devices. Additionally, the Specialist is responsible for assessment of device changes for regulatory implications.
Major Responsibilities
* Develop strategies for regulatory approval of medical devices.
* 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.
* Serve as internal consultant on regulatory issues such as submissions, recalls, advertising and promotional activities, field actions or review of proposed device changes.
* 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. Interact cross-functionally and with internal and external customers to complete tasks.
* Develop and deliver presentations to global regulatory agencies. Topics may include submission strategies/compliance issues.
* Research regulatory requirements for assigned geographies. Monitor emerging trends and integrate new requirements into department procedures and toolkits.
* Participate in training and mentoring of staff.
* Participate in department development initiatives.
Education & Competencies
* 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.
* 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.
* 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.
* Plans, organizes and prioritizes own daily work routine to meet established schedule.
* 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.
* 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.
* May provide limited work direction and guidance to exempt and/or skilled non-exempt levels of employees. May be asked to evaluate performance of and assist in career development planning for subordinates.