Director of Regulatory Affairs and Patient Safety

Baltimore, MD
May 10, 2018
Jun 01, 2018
Contract Type
Full Time
What You Will Do:

Primary Function:

The Director of Regulatory Affairs and Patient Safety assumes responsibility for the coordination of activities related to accreditation and regulatory compliance, provides comprehensive assessment of organizational needs to identify strategies to improve organizational performance and clinical outcomes and serves as a leader in the on-going advancement of a “Just Culture” that promotes the non-punitive reporting of potential safety concerns. This role will drive safety innovation through the identification and deployment of Patient Safety activities. Supports the organizational journey towards becoming a High Reliability Organization.

Collaborates with various interdisciplinary teams (i.e. Patient Safety Officer, Risk Management, Quality, Infection Prevention, Nursing, Pharmacy, Providers and other clinical care providers) to achieve organizational goals related to Patient Safety, Medical Staff and Regulatory Affairs. Assumes responsibility for the design and implementation of patient care delivery systems which promote collaboration among disciplines, facilitates the cost effective utilization of resources and supports the achievement of the hospital’s clinical outcomes, quality care and business objectives. Demonstrates personal leadership through activities at the strategic and operational level through innovative contributions to the organizational mission through the selection, development and work product of select management staff.

Duties and Responsibilities:
  • Collaborates with executive and leadership staff to identify strategic plan and annual priorities and assists with the alignment of resources for the greatest impact. Develops and maintains ongoing communication with clinical units, colleagues, and regulatory agencies to promote the delivery of high quality clinical care.
  • Provides advanced expertise in the delivery of health care, interpretation of clinical issues, and review of clinical practice to evaluate standards of care. Works to develop standardized practices based on analysis of clinical outcomes and patient safety opportunities while integrating regulatory requirements. Collaborates to develop and/or update policies, procedures and clinical standards and operationalize such standards to ensure compliance with hospital policy and procedures.
  • Acts as Survey Coordinator for Joint Commission and CMS surveys, and clinical compliance investigations. Coordinates follow up and communication with Regulatory Agencies. Submits Evidence of Standards Compliance and Measures of Success documentation as required by Joint Commission according to established timeframes.
  • Participates in establishing objectives directed toward Joint Commission and other regulatory compliance activities. Facilitates annual completion of Joint Commission Periodic Performance Review (PPR) process and is responsible for the actual submission of the PPR. Facilitates tracer activities related to organizational accreditation and regulatory standards to ensure ongoing compliance.
  • In conjunction with Executive Leadership, Risk Management and the Chief Medical Officer, coordinates and facilitates interdisciplinary Root Cause Analysis of significant events and near misses. Uses an interdisciplinary approach to issues and ensures that staff involved in events are provided the opportunity to provide input into investigation and action planning to prevent reoccurrence. Creates and submits summary documents to regulatory agencies within established time frames.
  • Responsible for developing, operationalizing, maintaining and evaluating the Patient Safety Program, evaluating the Culture of Safety and facilitating progress toward becoming a High Reliability Organization (HRO). Responsible for establishing a Patient Safety/HRO committee that includes the engagement of leadership in communication of issues and improvement strategies and which ultimately reports through the Patient Quality and Safety Council. Activities include participation in untoward event investigation and coordination of systems improvements to prevent reoccurrence.
  • Collaborates with pharmacy and clinical leadership regarding review of medication errors and evaluates potential for system improvements. Collaborates with the Directors of Performance Improvement, Risk Management, Patient Safety Officer and the Environmental Safety Officer and other key stakeholders in the development of policies and procedures. Works directly with department/unit leaders to monitor progress and ensure timely implementation of strategies identified.
  • Conducts focused assessment of conditions requiring correction, and facilitates inter-professional involvement in the development and implementation of practice changes or technologic solutions that address the interests of all clinical care providers. Monitors clinical outcomes to evaluate improvements, identify trends and emerging issues and presents information to Patient Quality and Safety committee.
  • Provides direct supervisory leadership for Patient Safety Officer. Develops an organizational environment that supports professional development and effective performance of staff and managers. Creates management systems that assure the achievement of organizational goals and promote the performance and retention of staff and are responsive to identified needs for change.
  • Assures compliance with standards of professional practice for nursing and allied health professionals and assures the competence and effectiveness of staff who provide patient care and support services. Assures compliance with regulatory requirements within service lines and in clinical areas.
  • Maintains competence in the performance of job responsibilities through self-improvement activities, participation in hospital and departmental activities and committees and education offerings. Performs other duties as assigned.

What You Need to Be Successful:


Knowledge of accrediting and regulatory requirements, survey and licensing policies and procedures.

Knowledge of performance improvement principles, methods and techniques. Demonstrated experience with successful implementation of clinical improvement projects at the organizational level is required. RN licensure required.


Master’s Degree in Nursing or BSN and MBA required.


Seven to Ten years of leadership experience including acute care quality and regulatory compliance.

We are an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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