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.The Senior Regulatory Affairs Specialist will also provide support to the functional project teams on Biological Evaluations for new and existing products/indications and will be responsible for implementing biological evaluation plans.Key Responsibilities:Lead the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products.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.Coordinate multiple projects at one time and provide regular reports to regulatory management and others as required.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 labeling/instructions for use for compliance with applicable local and international regulations.Recommend changes for labeling and internal documentation, reports for regulatory compliance.Support/prepare biological evaluation plans and reports for marketing, regulatory affairs, clinical affairs design review, post-market surveillance, and reimbursement purposes.Become the Subject Matter Expert (SME) for our Client’s Biological safety process.Work closely with Regulatory and Clinical Affairs to address biological aspects for submissions to EU/US regulators, including responding to requests from Regulators.Maintain an excellent understanding of the global medical device regulations especially with respect to Biocompatibility, for example, ISO 10993, by identifying and critically assessing emerging standards, theories, and methodologies and applying gained expertise within our Client’s Biological safety processes.Conduct comprehensive evaluations of biological risks associated with medical devices, ensuring compliance with ISO 10993 and regulatory requirements.Key Requirements:Level 8 Honor’s Degree Science or Engineering bachelor's degree/master's with a minimum of 3 years relevant experience with medical devices.Regulatory experience in Medical Devices, Pharmaceuticals, or similar regulated 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.Previous experience supporting or preparing biological evaluation plans.Ability to effectively manage multiple projects and priorities.Excellent attention to detail and results-oriented.For further information please contact Loretta Flynn at 086-1838380.Seniority LevelMid-Senior levelEmployment TypeFull-timeJob FunctionScienceIndustriesMedical Equipment Manufacturing and Pharmaceutical Manufacturing
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