Harmonics currently have an opportunity for a Regulatory Affairs Specialist. This is a 6 month contract which has the opportunity for remote working.
- Act as RA team member on IVDR remediation project.
- Review and approval of design documentation, verification protocols & reports etc. as required.
- Compilation of IVDR Technical documentation in compliance with requirements of IVDR including:
- STED including GSPR (General Safety & Performance Requirements).
- APR (Analytical Performance Report)
- CER (Clinical Evidence Report).
- PER (Performance Evaluation Report).
- Review and approval of all product labeling including IFU’s in compliance with IVDR requirements.
- Communication to management on Regulatory affairs issues, which require addressing.
- 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.
For more information on this position apply online and a member of the Harmonics team will be in touch
All applicants must be eligible to work in Ireland