Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
The Program Manager, Regulatory& Accreditation Affairs is responsible for leading the Nemours Children’s Health, Florida Regulatory and Accreditation program, and managing the respective team(s). The Program Manager's primary goal is to ensure that the Nemours Children’s Health, Florida (NCH-FL) remains compliant with all Federal, State and local regulatory requirements, and adheres to all identified accreditation and certification program standards. The Program Manager is expected to collaborate with the Director, Patient Care Services leaders, and others to craft a vision for a best-in-class program that ensures continuous survey readiness, proactive identification and response to emerging regulatory and enforcement trends, and the sustainability of process and culture around regulatory compliance. The Program Manager will be expected to operationalize that vision in partnership with other key stakeholders including nursing, medical and operational leadership. The Program Manager is expected to serve as a subject matter expert and resource, for the team(s) and committees, for the Q&S Department and for the organization as whole. The Program Manager will demonstrate exceptional critical thinking skills, develop a systematic approach to continuous compliance/readiness, lead and grow teams, and develop individual team members.
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