Regulatory Affairs Specialist

CPL

Galway

Regulatory Affairs Specialist.  The Regulatory Affairs Specialist will support Product Development, Regulatory Complaint Management and Regulatory Approval on sustaining projects. This is a 12-month fixed term contract. Job Responsibilities. Support the creation & maintenance of product design and technical documentation in compliance with the relevant regulations and standards. Support the development and submission of high-quality regulatory files to the relevant ethical committees and regulatory agencies, ensuring successful approval. Organise and maintain regulatory submissions with regulatory authorities. Co-ordinate and, where appropriate, conduct gap assessment activities in line with updated regulatory requirements and standards. Keep up to date with changes in applicable regulatory requirements and standards. Assist company preparation for inspection by a notified body and regulatory authorities. Co-ordinate and progress Adverse Event reporting to regulatory authorities. Ensuring adherence to all organisational and external regulatory requirements. Candidates Requirements. Level 8 or 9 degree in Science or related disciplines. Minimum of two (2) years of related experience in Regulatory Affairs, Quality or Design Assurance an advantage. Experience of preparing technical documentation for submission to regulatory agencies. Class III medical device experience is preferred. Working knowledge of GMP, FDA QSR and ISO 13485 requirements. Excellent communication, organisational and time management skills. For an immediate interview please forward your CV using the apply button. Or call Megan Warr on 091507515 for a confidential conversation.

1253 days ago