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Summary:The Project Manager, Global Regulatory Affairs Compliance and Planning will lead or support regional and global projects by effectively delivering assigned projects within GRA on time and within budget.
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Reporting to the Chief of Regulatory Affairs in the Department of Regulatory Affairs & Patient Safety the Project Manager for Patient Safety & Regulatory supports the department in coordination with hospital leadership, through management of projects related to patient safety and regulatory risks.
$99,705 - $112,901 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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As a Regulatory Affairs Project Manager you will have the opportunity to work with internal and external teams for project/product realization, write and prepare submission packets for health authority marketing approvals, and utilize agile principles to drive regulatory activities for our Companion Diagnostics Group (CDx.
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You have experience in Healthcare Regulatory Affairs. You have 5+ years experience, (5-10 years preferred), in Regulatory, R&D, Quality, Operations and/or Clinical. You have a good understanding of complexities and challenges in a global regulatory environment.
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The Manager, Regulatory Affairs – Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. Manager, Regulatory Affairs - Regulatory Project Manager.
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Manager, Regulatory Affairs - Regulatory Project Manager page is loaded. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for assigned projects and activities to achieve regulatory milestones and deliverables successfully and in a timely manner.
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You identify and act on opportunities for improvement within Quality & Regulatory, while embracing new technologies and other means to simplify and increase productivity. You work on regulatory submissions, have a deep understanding of healthcare regulatory framework, and how to maintain compliance while accelerating innovation for customers and patients.
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Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics. Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics.
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As a Senior Manager/Associate Director, Global Regulatory Affairs Project Lead you will be a part of our Global Regulatory Affairs organization. Minimum of 5 years of experience in Regulatory Affairs, preferably in development phase.
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As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory and business issues to enable products, including capital equipment and software products, that are developed, manufactured or distributed to meet required legislation.
$95,000 - $190,000 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Regulatory Affairs Project Manager. This individual contributor leads project submissions for FDA and EU regulatory approvals and acts independently to identify and resolve problems.
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Participate in Prevost and Volvo governance for regulatory affairs. Provide support to all areas of the business in regulatory compliance. Maintain documentation of regulatory compliance processes.
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This person will be a key member of Regulatory Affairs project teams to accomplish tasks that are instrumental to the company’s success. Attend clinical operations internal meetings as the Regulatory Affairs representative; and.
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Ability to building relationships between Regulatory Affairs and other areas of the organization: ability to communicate effectively at all levels. Provide regulatory direction to development project teams as a core team member; helps develop regulatory strategy for new products.
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Apply FDA regulations to business practices and provides regulatory input, advice and guidance to design teams. Assemble, distribute, store, track and retrieve information pertinent to the regulatory process, including the regulatory submissions process.
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regulatory affairs jobs Title: regulatory affairs project manager
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