Sr. Regulatory Affairs Specialist

### Responsibilities

Establish and maintain positive relationships with patients, visitors, and other employees. Interact professionally, courteously, and appropriately with patients, visitors, and other employees. Behave in a manner consistent with maintaining and furthering a positive public perception of Stamford Health and its employees.

Contribute to and participate in the Safety and Quality Improvement activities of the assigned department and the organization as needed. Contribution and participation include preparing the organization for survey/investigation visits and supporting departments within the hospital for departmental surveys. The Senior Regulatory Specialist will participate in committees as determined by the Administrative Director. Consistent adherence to the specific rules and regulations of Stamford Hospital, including:

• Safety and Security Policies
• Risk Management
• Infection Control Policies and Procedures
• Patient and Customer Service

### Senior Regulatory Affairs Specialist Responsibilities

• In collaboration with the Administrative Director, Regulatory Affairs, lead or assist with ongoing investigations, including coordination of interviews and documentation and communication of such to appropriate personnel in the organization.
• Assist when Federal/State/Stamford Health Emergency Operations Plan is activated regarding the communication of regulatory information as directed by the Administrative Director or other leadership.
• Respond to regulatory inquiries with internal and external customers.
• Research and prepare responses to internal and external regulatory agency inquiries.
• Prepare for survey/investigations on an organizational and departmental level.
• Facilitate regulatory surveys and follow up as needed.
• Provide expertise and assist departments in determining appropriate regulatory plans of correction.
• Monitor and ensure compliance with regulatory action plans.
• Prepare and submit regulatory mandatory documentation, applications, and all necessary updates to ensure regulatory compliance.
• Develop, review, and revise Department and Hospital policies as necessary.
• Coordinate or participate in Hospital and regulatory committees as necessary.
• Coordinate, prepare, and present regulatory education and updates for staff and leadership at all levels as necessary.
• Interface with the Health Information Management Department and other departments as necessary to ensure efficient processing of inquiries from regulatory agencies.
• Perform other related duties as assigned or requested to maintain a high level of service.
• Complete required continuous training and education, including department-specific requirements.
• Demonstrate professional work behavior by following the Stamford Health Service Standards and Success factors. Comply with departmental organizational policies and procedures and adhere to external agency requirements.
• Participate in the Sentinel Event Review Panel to provide regulatory guidance as needed.
• Co-chair the Regulation & Accreditation Committee.
• Participate in rotating after-hours Department on-call duties.

### Performance Improvement Functions

• Ensure timely identification of events to ensure compliant reporting to the CT Department of Public Health (DPH).
• Interface with other departments to promptly and effectively address patient care issues or complaints with potential regulatory noncompliance or impact.
• Develop and maintain programs for tracking and trending significant and/or reportable occurrences.
• Coordinate or participate in Performance Improvement committees as necessary.
• Work with the Regulatory Affairs team to determine areas of opportunity for regulatory compliance.
• Communicate regulatory findings and compliance to departments; escalate to leadership as needed.

### Regulatory Functions

• Assist with the identification and development of plans of correction and ensure timely reporting to DPH and other regulatory agencies pursuant to legislative and regulatory guidelines (e.g., Adverse Events, Med Sun, Joint Commission).
• Provide guidance to other departments under the supervision of the Administrative Director of Regulatory Affairs in preparation for regulatory surveys and site visits.
• At the direction of the Administrative Director of Regulatory Affairs, coordinate or participate in meetings with regulatory agencies.
• Coordinate efforts to provide assistance to regulatory agencies in response to inquiries or requests for information and/or medical records consistent with Department and Hospital policy.
• Function as the Hospital’s regulatory liaison as needed or directed.
• Assist with or coordinate all phases of preparation for surveys/inspections, including but not limited to TJC, CT DPH, CMS, DEEP, NRC, DEA, and DCP.
• Assist with completion and submission of key regulatory applications, including CT DPH, TJC, and CMS.
• Participate as needed in meetings with regulatory and accrediting agencies.
• Assist with coordination of efforts to provide assistance to regulatory agencies in response to inquiries or requests consistent with legislative, regulatory, accrediting, and Hospital policy.
• Participate as a key member to support various committees in support of regulatory compliance.
• Interface with departments.

### Educational Functions

• Provide in-service training at new employee orientation sessions regarding regulatory surveys, regulatory compliance, and regulatory department functions.
• Participate in and/or attend educational seminars and conferences.
• Develop staff educational programs regarding DPH, CMS, OSHA, DCP, Joint Commission, and other regulatory agencies’ reporting and programs as requested or determined by the Administrative Director, Regulatory Affairs.

### Qualifications

• Registered Nurse or other credentialed healthcare professional is required.
• Bachelor’s degree in nursing, hospital administration, or a related field from an accredited college is required; master’s degree preferred.
• A minimum of 3 to 5 years of clinical nursing or other hospital experience is required.
• 3 to 5 years of prior regulatory compliance experience in an acute care setting is required.
• Specialty Certification preferred.
• Excellent written, oral, and communication skills are essential.
• Demonstrated organizational skills are essential.
• Expertise in the utilization of quality improvement methods related to data management and analysis is required.
• Experience developing and conducting educational programs.
• High level of competency with computer software such as MS Office or equivalent is required.

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