Harmonics currently have an opportunity for a Regulatory Affairs Specialist. This is a 9 month contract which has the opportunity for remote working.
In this role you will have the opportunity to:
- 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 BCII.
- Sc. level 8 in a scientific field or other relevant technical field.
- A minimum of 1 years’ experience in a QA or RA role within a manufacturing facility.You will be qualified to a minimum of B.Sc. level in a scientific field or other relevant technical field with
- IVDD Directive, associated harmonised standards and IVD Regulation.
- ISO13485 and the FDA QSRs.