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The Regulatory Specialist under the supervision of the Director of Accreditation and Regulatory Affairs has responsibility for site visit preparation, coordination of site visit logistics and response, as well as assist in preparing report-out to management of major regulatory changes and issues of mock or real survey results.
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In collaboration with Director Accreditation and Regulatory Affairs develops and disseminates mock and real survey issues related to regulatory standards and hospital policy compliance.
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Job Summary The Senior Manager, Regulatory Affairs position will support the Regulatory Affairs (RA) Director to help define the regulatory strategy for our innovative next-generation technology for cellular therapy.
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This position is for the Risk & Regulatory Intake and Reporting Controls team with in AMCB D&A Data Governance. Assist with facilitation & management of regulatory, audit, litigation, enhanced monitoring, and 2nd line data requests included support to our federated partners supporting Controls in data and reporting.
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Drafts and updates work instructions relative to the Regulatory Affairs department. Identifies, completes, and files all necessary documentation as required with applicable Regulatory bodies, both domestic and international for product registrations.
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Under guidance of the Medical Affairs team, create and modify multimedia scientific materials for conference submissions; perform other duties as assigned to support medical affairs. CooperSurgical’s Medical Affairs department is seeking an intern to support the Medical Affairs team, with a primary focus on assisting with the creation and execution of research projects, data aggregation, and manuscript writing across key areas of the business.
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The Federal Affairs Analyst will support leadership in the development of thought leadership initiatives to address emerging federal health policy issues. The Analyst will work with the business and Government Affairs leadership to identify potential operational and policy impacts.
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Design and implement Regulatory Affairs strategies, policies and objectives in accordance with Company strategic plans. Assists with the training of regulatory affairs personnel and provides direction on specific projects.
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About CooperSurgicalCooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life.
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