Harmonics Recruitment are hiring for a Reg Affairs Specialist for a growing MNC in the Mid West
- RA representative on Design Change projects.
- Preparation and maintenance of CE technical files and 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 labeling.
- 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.
- Will be 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 within the organisation
- 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