Our client a pharmaceutical company in Clare is looking to recruiter a Regulatory Affairs Analyst for their site.
- RA representative on Design Change projects.
- Preparation and maintenance of CE technical files in compliance with current IVDD and preparation for compliance to new IVDR.
- Preparation and submission of dossiers and registration documentation for new product registrations and renewal of existing licenses.
- Management of Field Action process for AU products.
- Review and approval of device modification proposals.
- Review and approval of all product labelling.
- Control of distribution of product from regulatory perspective through regulatory stop ship program
- Participation in Internal and External Quality Audit as required.
- Participation in Management Reviews of the Quality & Environment System as required.
- Communication to management on Regulatory affairs issues, which require addressing.
- Support, where required, in Global RA tasks / projects, which may include supporting RA colleagues outside of the company.
- Qualified to a minimum of B.Sc. level in a scientific field or other relevant technical field.
- Have a minimum of 1 years’ experience in a QA or RA role within a manufacturing facility.
- Excellent written and communication skills are essential, which will result in strong working relationships cross functionally.
- Ability to work in a very busy environment, ability to manage change effectively in order to better serve our internal customers, external customers and legislative demands.
- Knowledge and understanding of the IVDD Directive and the associated harmonised standards.
- Knowledge and understanding of ISO13485 and the FDA QSRs.
- Experience of product registrations is desirable.
For further information on this Regulatory Affairs Analyst role in Clare please contact Clara Burke on 0868168273/ firstname.lastname@example.org
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