Regulatory Affairs Specialist

Harmonics currently have an opportunity for a Regulatory Affairs Specialist. This is a 6 month contract which has the opportunity for remote working.

In this role you will have the opportunity to:

• 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.

The essential requirements of the job include:-

• 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

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 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