Senior Regulatory Manager

Regulatory Compliance Lead

Leads regulatory surveys and promotes utilization of continuous quality improvement (CQI) principles, methods, and tools. Directs, investigates and resolves regulatory compliance concerns. Leads coordination with Quality, Education and Operational management to ensure the continual improvement of regulatory compliance by company facilities. Ensures compliance by company facilities to federal, state and local laws and regulations. Serves as regulatory expert and resource.

Principal Duties And Responsibilities

• Leads Clinical, and Operational teams in creating and sustaining a culture of regulatory compliance.
• Acts as lead amongst Quality, Education and Technical departments to provide educational activities as needed to achieve compliance with federal, state, and local laws and regulations. Using expertise, makes recommendations, provides guidance, and influences through education to re-establish regulatory compliance.
• Identifies improvement opportunities to ensure compliance with company standards, policies and procedures, as well as federal, state and local regulations by conducting facility audits. Conducts exit conferences with facility management staff to review survey findings and to make recommendations. Provides guidance to operations in the development, implementation and monitoring of a Plan of Correction (POC), improvement projects and activities.
• Using expertise and independent judgment, works with facility, area and regional management staff to set and achieve improved regulatory and operational outcomes, identify risk areas and opportunities for improvement, and assist with root cause analysis, if indicated. Monitors, trends and analyzes audit results, ensures thorough root cause analyses and recommends process changes as identified.
• Provides guidance, interpretation and subject matter expertise when appropriate.
• Conducts facility mock surveys to evaluate conformance to state licensure and CMS Conditions of Coverage to ensure safe operational condition and external survey readiness.
• Educates and advances the use of the Quality Assessment and Improvement (QAI) Program tools and promotes utilization of Continuous Quality Improvement principles to ensure adherence to standard QAI activities, tracking and trending of required metrics, and identification and prioritization of performance improvement projects. Ensures the use of appropriate tools and monitoring techniques to assist staff and QAI committee members in assessing their compliance.
• Mentors and assists facilities in identifying effective practices applicable to their needs, in testing for desired results, and the adoption and implementation of these practices.
• Analyzes, manages, and reports data to identify improvement opportunities and measure progress of improvement projects.
• Prepares and disseminates reports on audit findings and corrective and preventive action recommendations to Regulatory Affairs, Quality as well as operations management and corporate staff, and as needed.
• Provides guidance and consultation to facilities and area management in their development and evaluation of plans of corrections in response to state and federal surveys.
• Conducts emergent mock surveys and coordinates rapid response teams to assist with intervention and resolution of critical facility specific problems. Ensures thorough root cause analysis, and acts as Lead in identifying and prioritizing areas of risk and opportunity.
• Fosters and maintains good working relationships with state survey agencies, CMS regional offices, ESRD Networks and other regulatory bodies that have jurisdiction over facilities.
• Fosters and maintains good working relationships with the ESRD professional community to promote the company as an industry leader
• Maintains up to date expert knowledge of CMS Conditions of Coverage for ESRD facilities, state regulations, quality improvement concepts, principles and practices to perform tasks and duties, and clinical and administrative policies and procedures, available internal resources.
• Performs other related duties as assigned.

Physical Demands And Working Conditions

Supervision

Education And Required Credentials

Experience And Skills

Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.