Regulatory Affairs IVDR Specialist

Job Description

Our client a leading Diagnostic Compnay are seeking a Regualatory 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 RESPONSIBILITIES

• 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