Senior Regulatory Affairs Specialist (Hybrid) CREGG have an exciting opportunity for an experienced Regulatory Affairs Specialist to join our Galway based multinational medical device manufacturer. Hybrid role offering a great work life balance. Please email your CV to or call Rachel on. Key Responsibilities : Responsible for regulatory activities of EMEA countries to launch and secure the products in the markets. Basic understanding of laws and regulations of the responsible EMEA countries. Assist the Head of Departments in responding to all product-related inquiries and actions by regulators and internal departments. Assist in preparing and filing necessary documentation for applications with international government agencies for product registration and coordinating advice on technical aspects of product labeling, product dossiers, claims substantiation/localization, and product registrations Review marketing materials for compliance with advertising law and scientific substantiation. Review product labels for compliance with local labeling regulations for medical devices, general wellness, supplements, and cosmetics. Qualifications: Bachelor's degree in a relevant discipline Minimum 2 years of experience in regulatory affairs in medical device Strong attention to detail and time management skills Excellent communication skills, both written and oral For further information please contact Rachel Mc Mahon INDTRAC Skills: ISO13485 Product labelling claims substantiation
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