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Engages with cross-functional team members in Clinical Affairs, Operations Center of Excellence, Professional Affairs, Health Economics and Market Access, R&D, Regulatory, and Medical Safety and Infection Prevention & Control to review clinical evidence and to evaluate a product’s risk-benefit calculus.
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Minimum of 10 years of biotechnology/pharmaceutical/medical device industry experience in medical affairs, medical technology, medical strategy with experience in all phases for development projects and regulatory space or combination of relevant clinical practice, training, and education.
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Minimum of 3 years experience working with utility regulatory accounting and/or FERC accounting guidelines, preferably either at a utility, FERC or at a consulting firm. Stay current with legislation including federal, state and local requirements for regulatory accounting and FERC accounting practices.
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Serve as the primary business partner in forecasting, reporting and consulting for the Global Quality, Regulatory and Corporate Finance functions. The individual will provide reporting, analytics, planning and accounting support primarily for the Global Quality, Regulatory and Corporate Finance functions.
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Technical/Functional Skills Experience Required Critical National Infrastructure (CNI) department currently provides IT support services for Energy Management Systems (EMS), Outage Management Systems (OMS), and Gas Management System (Client) applications that drive the companys operations
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My client seeks a highly motivated Director of Regulatory Affairs to join their growing organization. Prepare global regulatory applications, including US medical submissions (pre-submissions, 510ks, IDEs, and annual reports) and EU MDR, and design dossiers and technical files for other international markets.
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May direct and coordinate activities of less senior Regulatory Affairs staff, including coaching, mentoring, advising and providing feedback. Provides Regulatory Affairs guidance throughout the product development cycle, and coordinating team inputs for submissions.
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Job DescriptionLeads and directs regulatory compliance communications to ensure compliance of the Global Quality System with applicable regulatory requirements and with the business strategy of the company.
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The Senior Director of Quality, Product Safety and Regulatory Compliance leads a team of experts in quality, product safety, product regulatory compliance, and risk management. 10+ years of relevant experience in quality, regulatory compliance, and product safety.
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Skills: SOP, FDA, Regulatory Affairs Operations, GMP (Good Manufacturing Practice) Regulatory Affairs Specialist. Regulatory Affairs Certification(s) (U.S., EU or Global) desirable.
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The focus is supporting the Development, Regulatory, and Asset Management parts of the business by working with the utilities and customers on interconnection documents, securing incentives, submitting permit applications, and organizing the development phase of complex projects.
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Support Beauty Liquid regulatory affairs to develop/update document tracking programs and associate processes. Drive initiatives for process improvements in regulatory affairs.
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The Director of Regulatory Affairs is responsible for activities to lead and maintain global regulatory approvals to market devices throughout the product development lifecycle. Education Required Bachelor’s degree, preferably in an engineering or life sciences discipline;Masters in Regulatory Affairs or Regulatory Affairs Certification (RAC) is a plus.
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