Director, Clinical Risk Management & Regulatory Affairs

SUMMARY:

The Director, Clinical Risk Management & Regulatory Affairs provides strategic and operational leadership for the health system's clinical risk management, regulatory readiness, accreditation, and risk mitigation programs. The Director establishes an integrated approach for identifying, evaluating, reducing, and monitoring organizational risk while supporting compliance with applicable federal, state, accreditation, licensing, and reporting requirements.

As a trusted advisor to executive leadership, medical staff, nursing, legal counsel, and operational leaders, the Director interprets regulatory expectations, coordinates responses to inquiries and surveys, oversees clinical risk review and claims-related activities, and promotes reliable systems that protect patients, team members, and the organization. The Director leads a multidisciplinary team and supports transparent, timely escalation of significant risk and compliance concerns.

ESSENTIAL FUNCTIONS:

STRATEGIC RISK AND REGULATORY LEADERSHIP:

·        Develop and execute an enterprise clinical risk management and regulatory affairs strategy aligned with organizational priorities.

·        Advise leaders on material clinical, operational, regulatory, and accreditation risks and recommended mitigation actions.

·        Establish methods for risk identification, prioritization, escalation, monitoring, and closure.

·        Promote a proactive, systems-based approach to reducing liability exposure and regulatory risk.

CLINICAL RISK MANAGEMENT:

·        Direct the clinical risk management program across inpatient, ambulatory, and other designated care settings.

·        Lead efforts to reduce serious safety events and preventable harm.

·        Oversee review and investigation of events with potential liability, regulatory, or reputational implications.

·        Evaluate trends and recommend controls, process changes, education, or other actions to lessen risk.

·        Partner with Patient Safety and operational leaders to ensure coordinated review without unnecessary duplication.

·        Provide consultation regarding disclosure, documentation, preservation of information, and risk-sensitive communications in collaboration with Legal Services.

EVENT INVESTIGATION AND ORGANIZATIONAL LEARNING:

·        Oversee, facilitate, and assist with event review sessions, including Root Cause Analyses, Action Plan reviews, safety debriefs, hot washes, and learning reviews, as indicated.

·        Ensure corrective actions are specific, measurable, implemented, monitored, and sustained.

·        Establish processes to spread lessons learned across the health system.

·        Use systems-based methods to identify vulnerabilities and strengthen barriers and controls.

CLAIMS AND LITIGATION COORDINATION:

·        Coordinate timely notification, documentation, review, and follow-up for claims and potential claims in partnership with legal counsel and insurers.

·        Support fact development, record preservation, case review, and organizational response activities.

·        Monitor claims themes and collaborate with leaders on targeted risk-reduction strategies.

·        Maintain appropriate confidentiality and legal protections for sensitive risk-management information.

REGULATORY AFFAIRS AND ACCREDITATION:

·        Maintain continuous readiness for applicable accreditation surveys, government reviews, licensing activities, and regulatory inquiries.

·        Monitor, interpret, and communicate changes in regulatory and accreditation requirements.

·        Coordinate organizational assessment, readiness planning, evidence collection, survey support, and corrective-action response.

·        Ensure regulatory commitments, plans of correction, and follow-up actions are assigned, monitored, validated, and closed.

·        Serve as an organizational liaison with regulatory, accreditation, licensing, and government agencies as assigned.

·        Facilitate organizational FMEA projects in alignment with regulatory requirements.

POLICY, STANDARDS AND COMPLIANCE INTEGRATION:

·        Partner with policy owners to align policies, procedures, and practices with regulatory and accreditation expectations.

·        Develop and maintain tools, guidance, education, and readiness resources for leaders and staff.

·        Identify areas of noncompliance or vulnerability and facilitate timely corrective action.

·        Collaborate with Compliance, Legal, Quality, and Patient Safety to clarify accountability and escalation pathways.

RISK ANALYTICS, REPORTING AND GOVERNANCE:

·        Develop risk, regulatory, accreditation, claims, and readiness dashboards for executive and board oversight.

·        Analyze trends, recurring findings, exposure patterns, and corrective-action effectiveness.

·        Provide concise reports and recommendations to executive leadership, governance committees, and medical staff bodies.

·        Maintain reliable records and reporting processes that support auditability and organizational learning.

PEOPLE, PROGRAM AND RESOURCE LEADERSHIP:

·        Recruit, develop, and retain a high-performing team with clear roles, competencies, performance expectations, and development plans.

·        Set priorities, allocate work, monitor deadlines, and ensure consistent service across the health system.

·        Manage assigned budgets, contracts, vendor relationships, insurance-related resources, and information systems.

·        Promote cross-training, succession planning, professional development, and disciplined program management.

EMERGENCY AND HIGH-RISK RESPONSE:

·        Provide risk and regulatory consultation during significant events, urgent reviews, unannounced surveys, and other high-risk situations.

·        Coordinate rapid information gathering, leadership communication, external response, and corrective-action tracking within the role’s authority.

·        Ensure sensitive matters are handled with professionalism, tact, diplomacy, and appropriate confidentiality.

·        Serve as the key organizational lead for the CANDOR program.

·        Adhere to TMCH organizational and department-specific safety, confidentiality, values, policies, and standards.

·        Performs related duties as assigned.

MINIMUM QUALIFICATIONS

EDUCATION:

·        Master's degree in Nursing, Healthcare Administration, Public Health, Risk Management, Law, Business Administration, or a related field required.

EXPERIENCE:

·        Five (5) years of progressive healthcare risk management, regulatory, accreditation, quality, patient safety, legal, or clinical leadership experience required.

·        Three (3) years of leadership experience managing people, programs, or departments required.

·        Demonstrated experience with regulatory readiness, accreditation surveys, clinical risk assessment, investigations, and corrective-action management required.

·        Experience in an acute care hospital or integrated health system preferred.

·        Experience coordinating claims, litigation support, or insurer relationships preferred.

LICENSURE OR CERTIFICATION:

·        Certified Professional in Healthcare Risk Management (CPHRM) preferred.

·        Certified Professional in Patient Safety (CPPS), or comparable regulatory, accreditation, compliance, or risk credential preferred.

KNOWLEDGE, SKILLS AND ABILITIES:

·        Advanced knowledge of healthcare risk assessment, risk mitigation, regulatory reporting, accreditation readiness, claims management, and corrective-action principles.

·        Knowledge of federal and state healthcare requirements and accreditation standards applicable to hospital and health system operations.

·        Ability to interpret complex requirements, assess organizational impact, and provide clear, practical guidance.

·        Strong executive communication, investigation, facilitation, negotiation, change leadership, and conflict-resolution skills.

·        Ability to respond to sensitive or confidential inquiries from regulators, government agencies, patients, attorneys, insurers, and organizational leaders.

·        Ability to define problems, collect and evaluate facts, draw valid conclusions, and exercise sound independent judgment in high-risk situations.