|Role Type||Fixed Term Contract|
Regulatory Affairs Specialist
Job ID: JOB-11511
Regulatory Affairs Specialist (ftc)
My client is a pleased to offer a Regulatory Affairs position as their Clare manufacturing site. In this role you will work with the Regulatory and Quality teams to ensure device compliance.
As the RA Specialist, your role covers:
- RA representative on IDP and Design Change projects.
- Review & approval of Design verification & validation protocols and reports
- Development and implementation of registration strategies for new product launches.
- Support Preparation and submission of 510k for US clearance.
- Preparation and maintenance of CE technical documentation in compliance with IVDR.
- Preparation and submission of dossiers and registration documentation for new product registrations and renewal of existing licenses.
Support, where required, in Global RA tasks / projects, which may include supporting RA colleagues outside of the organization.
- B.Sc. Degree qualified
- 1 + years’ experience in a QA or RA role within a manufacturing facility.
- It would be a plus if you also possess previous experience in:
- IVDD Directive, associated harmonised standards and IVD Regulation.
- ISO13485 and the FDA QSRs.
For further information on this role please contact Marchon Monroe on 086 044 9473/ email@example.com
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