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)
Position Description
The Regulatory Affairs Program Coordinator (RN) supports the Manager of Regulatory Affairs in various continual readiness and accreditation/regulatory compliance activities, including assisting with mock surveys. This position is responsible for the coordination of self-tracers, and for conducting process tracers including developing tracers, collecting, analyzing, and reporting tracer findings. This Coordinator uses their clinical expertise to advise and successfully collaborate with various levels of personnel including leaders, physicians, and team members.
Position Requirements
Associates Degree: Nursing and 2 years or more of experience in Acute care setting as a clinician/registered nurse. Skills required: Computer skills required to include Microsoft Word, Excel and PowerPoint, Data Abstraction and Management. Must be Registered Nurse with current valid Georgia license.
Preferred Requirements
Bachelor's Degree: Nursing. 5 years or more of experience in Acute care setting as a clinician/registered nurse. CPHQ certification.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
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