A cutting-edge Medtech leader based in Co. Clare are looking to hire a Senior Regulatory Affairs Specialist who 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.This position is responsible for providing support for assigned biological evaluation projects for both internal and external customers. The Senior Regulatory Affairs Specialist will provide support to the functional project teams on Biological Evaluations for new and existing products/indications. The role will involve implementing biological evaluation plans and reports to meet business targets, participating and interacting with project groups ensuring MDD/MDR Compliance, assisting with pre-clinical and clinical submissions and departmental projects as assigned.Role and ResponsibilitiesLead 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.Coordinates multiple projects at one time and provides 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.Recommends changes for labeling and internal documentation, reports for regulatory compliance.Keeps abreast of regulatory procedures and changes. Support review of internal procedures to ensure continuous compliance with all regulatory requirements.May have direct interaction with regulatory agencies on defined matters.Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives. Co-ordinate gap assessments against regulatory requirements.Communicates status of projects/submissions directly to senior management as required.Biological Evaluation SpecificSupports/prepares biological evaluation plans and reports for marketing, regulatory affairs, clinical affairs design review, post market surveillance and reimbursement purposes.Coordinates multiple projects at one time and provides regular reports to regulatory management, clinical affairs and others as required.Works closely with Regulatory and Clinical Affairs to address biological aspects for submissions to EU/US regulators, including responding to requests from Regulators.Maintains an excellent understanding of the global medical device regulations especially with respect to Bio-compatibility for example ISO 10993, and by identifying and critically assessing emerging standards, theories and methodologies and applying gained expertise within safety processes.Coordination with external biological laboratories on testing required and compilation of requirements to conduct same for example: samples, quotes, critical review of protocols, reports, etc.Communication with consultant/toxicologists/peer review within the client as necessary.Design and conduct literature searches on products, specific surgical indications, outcomes or other areas.A primary contact for biological working groups/training going forward.Supports pre-clinical and clinical activities as required.Conduct comprehensive evaluations of biological risks associated with medical devices, ensuring compliance with ISO 10993 and regulatory requirements.Develop and oversee biocompatibility testing strategies, including material characterization, in vitro, and in vivo studies.Ensure alignment with global regulatory standards (FDA, EU MDR, ISO 14971) and support risk management file development.Work closely with R&D, Quality, and Regulatory teams to mitigate biological risks and support product development and submissions.Qualifications and Education RequirementsLevel 8 Honor’s Degree Science or Engineering bachelor's degree/master's with a minimum of 3-5 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.You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.Provide guidance, coaching and training to other employees within job area.You have strong technical knowledge. You are skilled in thinking critically and making sound decisions. Ability to comprehend principles of engineering, physiology, and medical device use.Ability to effectively manage multiple projects and priorities.Has an excellent attention to detail and are results oriented.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionMedical Equipment Manufacturing
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