Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (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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