Regulatory Affairs Specialist (12 Month FTC)

CareerWise Recruitment

Galway

A Regulatory Affairs Specialist on a 12 Month Fixed Term Contract, is required by CareerWise Recruitment for our Galway based client. The Regulatory Affairs Specialist will support Product Development, Regulatory Complaint Management and Regulatory Approval on sustaining projects. Please contact Tom Devaney for more information. THE ROLE: * 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. REQUIREMENTS: * Level 8 (Minimum) or 9 Degree in Science or related disciplines. * Minimum of 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. Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the Medical Devices, Pharmaceuticals, Life Sciences, ICT, Engineering, Food and Agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

1249 days ago