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.About Your New Job as a Senior Reg Affairs Specialist:Responsible for providing support for assigned biological evaluation projects for both internal and external customers.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.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.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.What Skills You Need to succeed as a Sr Reg Affairs Specialist:Level 8 Honour’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.Seniority levelAssociateEmployment typeFull-timeJob functionManufacturing and EngineeringIndustriesMedical Equipment Manufacturing
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