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)
Job Summary
The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. This position concentrates on oversight of accreditation and certification processes, including but not limited to, The Joint Commission (TJC), Centers for Medicare and Medicaid Services (CMS), and State/Local Department of Health (DOH) standards, regulations and law, in consultation with JHHS Legal Counsel, as necessary.
This position involves interpreting and operationalizing regulatory requirements, including but not limited to:
Participating in regulatory-related communication/notification, staff/leadership education, and policy/documentation development or revision as needed
Coordinating virtual and onsite surveys by external regulatory/accreditation agencies
Coordinating onsite mock surveys by external consultants or JHHS Office of Accreditation & Certification (OAC)
Developing and implementing corrective actions and monitoring plans for sustaining improvements over time
Collaborating on special projects, as requested
Serving as a resource/consultant to internal and external customers
Participating in organization and/or health system committees
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