Regulatory Affairs Specialist with experience in the medical devices sector required for 12mth fixed term contract with medical devices mulitnational in Galway. You will support the product development, Regulatory complaint management and regulatory approval on sustaining projects.
- 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
- Bachelor’s or Master’s Degree in Science or related disciplines.
- Minimum of 2 years experience in Regulatory Affairs, Quality or Design Assurance
- Experience of preparing technical documentation for submission to regulatory agencies
- Experience working in a regulatory role within medical devices
- Working knowledge of GMP, FDA QSR and ISO 13485 requirements
- Excellent communication, organisational and time management skills
Please contact Emer Smith to discuss in confidence