Regulatory Affairs Specialist – Project related with longer-term prospects
The Regulatory Affairs Specialist will join the global project team and support the regulatory activities related to both ongoing and planned project activities in Ireland and for R&D sites as well as third-party manufacturer (TPM) sites globally.
Evaluate proposed changes for regulatory impact.
Review and approve study protocols and records that will from part of Regulatory submissions.
Work with the Medical Writing group on documentation required for regulatory submissions, ensuring tasks are completed on time.
Issue and follow up Notifications of Change as appropriate.
Assist with ensuring necessary documentation is provided to countries to facilitate timely completion of Regulatory submissions & acquisition of approvals.
Real time tracking of submission and approvals.
Ensure compliance with product post - marketing approval requirements.
Participates as a Team Member: Actively contributes to the team process, commits to team goals, expresses opinions and shares ideas freely.
Completes daily work to meet established schedule with guidance from supervisor on prioritization of tasks.
Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, company policies, operating procedures, processes and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Carries out duties in compliance with established business policies.
Demonstrates commitment to the development, implementation, and effectiveness of the Quality Management System per ISO, FDA, and other regulatory agencies.
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Education & Experience
Bachelor's degree in Science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology).
2+years’ experience in a regulated industry (e.g. medical products): experience in Regulatory Affairs would be an advantage.
Demonstrated experience reviewing and analysing documentation
Experience with EU and other international medical device regulations and submissions beneficial.
Competitive salary and good long term career options available with this large multi-national . This is a great opportunity to gain exposure to global markets and develop your regulatory affairs experience across a broad spectrum of responsibilities
For a confidential discussion and more information on the role, please contact Davin Ferguson.