Senior Regulatory Affairs Specialist Excellent opportunity for a Senior Regulatory Affairs Specialist to join a thriving company in Co. Clare. The Senior Regulatory Affairs Specialist will be responsible for developing and implementing regulatory strategies to support the timely and successful registration, approval, and maintenance of Company and Client products. This role involves collaborating with cross-functional teams to ensure compliance with applicable regulations and standards while facilitating product commercialization and market access. Key Responsibilities: Lead the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products. Drive FDA submissions and Technical File development for medical devices, ensuring alignment with regulatory strategy and global compliance requirements. Respond to requests from notified bodies; competent authorities and/ or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information Provide regulatory direction to development project teams as a core team member. Advise other functional units (engineering, marketing, operations, quality etc) of the requirements in each target market. Review proposed labelling/instructions for use for compliance with applicable local and international regulations. Recommends changes for labelling and internal documentation, reports for regulatory compliance. Coordinates multiple projects at one time and provides regular reports to regulatory management, clinical affairs and others as required. Support regulatory compliance activities, including manufacturing site registration and GMP audits as needed Key Requirements: Level 8 Degree in Science or Engineering Minimum 3 years experience in Regulatory Compliance experience in the Medical Devices industry is required. Understanding of applicable guidelines and regulations, for example experience with ISO 10993 Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745 and international regulatory agency requirements. Ability to effectively manage multiple projects and priorities. Has an excellent attention to detail and are results oriented. For further information please contact Loretta Flynn Skills: regulatory affairs ISO 10993 EU MDR