Job Description:
Our client, a leading Diagnostic company, is 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 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
emma.daly@collinsmcnicholas.ie
0861041202
