Job Description:
Our client, a world leading Rapid Diagnostic company based here in Galway, is seeking a Regulatory Affairs IVDR Specialist to join their Galway team on an initial 6-month contract this role is 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 the capacity to apply skills/knowledge within the context of specific needs or requirements.
Main Responsibilities:
As an Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing the development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
Interacts with regulatory agencies to expedite approval of pending registration.
Serves as regulatory liaison throughout the product lifecycle.
Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, and 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.
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