Job Description:
Our client a leading Diagnostic Compnay are seeking a Regulatory Affairs IVDR Specialist to join their Galway team on a 6 month contract | Fully onsite
Main Purpose of Role :
· Experienced professional individual contributor that works under limited supervision.
· Applies subject matter knowledge in the area of Regulatory Affairs.
· Requires capacity to apply skills/knowledge within the context of specific needs or requirements.
Main Resonsibilities :
· As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
· Interacts with regulatory agency to expedite approval of pending registration.
· Serves as regulatory liaison throughout product lifecycle.
· Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
· Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
· Serves as regulatory representative to marketing, research teams and regulatory agencies.
· Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
For a confidential discussion and more information on the role, please contact Emma Daly
emma.daly@collinsmcnicholas.ie
0861041202
