Experience Minimum 8 years of experience in Regulatory Affairs, of which a minimum of 5 years must be in IVD Regulatory Affairs. Minimum 5 years of experience in managing regulatory professionals including responsibility for staffing management, professional development, budget management and adherence with procedures, policies and regulations. Demonstrated success in obtaining regulatory approvals in the major geographies including but not limited to the US, EU (under IVDR) and other major geographies. Hands-on experience in preparing regulatory submissions including 510(k) and IVDR Technical Documentation and managing relationships and communications with Regulatory Agencies such as FDA, EU Notified Body, etc. Experience managing relationships with a variety of stakeholders and cross-functional teams. Experience with scientific writing and communications. Skills & Capabilities Strong knowledge of regulatory requirements for obtaining Regulatory Approvals in the United States, EU (under IVDR), Canada, and Australia. Working knowledge of regulatory requirements for obtaining global Regulatory Approvals in Asia Pacific, Latin America and Middle East. Strong knowledge of IVD product development process. Strong knowledge of requirements, methods and data analysis utilized in the analytical and clinical validation of IVD products. Understanding of CLSI guidelines preferred. Strong ability to understand and interpret complex scientific topics as it relates to regulatory requirements, regulatory intelligence, and policy and strategy. Strong skills in verbal and written communication including scientific writing and presentation. Strong ability to mentor, train, and develop skills of staff in regulatory knowledge and related processes. Ability to manage and coordinate the activities of direct reports. Strong skills in leadership, influence, and negotiation. Ability to lead cross-functional projects with a focus on collaboration and teamwork to a timely and effective conclusion. Ability to function effectively with ambiguity in a rapidly changing environment. Ability to develop proactive and creative approaches to problem solving. Advanced ability to organize and complete multiple tasks in a fast-paced environment. Advanced skills in Microsoft Office Suite: Word, Excel, Access, Outlook, Power Point, Visio, and Adobe Acrobat. Advanced knowledge of electronic publishing/file management system. #J-18808-Ljbffr BioTalent Ltd
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