Regulatory Affairs Manager jobs in the United States

Details

Posted : 09-Jan-25

Location : California

Categories :

Quality / Risk Management

Internal Number : 7127

Job Description

The Manager of Medical Affairs is a leader in the areas of Patient Safety and Peer Review, both of which are under Medical Affairs.?? The manager supports the Associate Directors in both areas and is responsible for leading initiatives to enhance patient safety / peer review and quality of care in a healthcare organization.?? This position oversees processes related to incident reporting, root cause analysis, and peer reviews to ensure compliance with regulatory standards and the implementation of best practices.?? The role involves close collaboration with many leaders across the organization within medical staff, academics, nursing, and operations to ultimately drive top notch clinical care that is consistent with evidenced based practice as well as drive a culture of safety and continuous improvement.

Primary Duties and Responsibilities

In collaboration with Associate Directors of Patient Safety and Peer Review, provides leadership, guidance, and direction for day-to-day operations and activities, including the authority to make independent decisions regarding operations, administration, and governance. Serves as a resource to hospital and Medical Staff leadership regarding the Patient Safety and the Peer Review processes.?? Provides consultation to medical staff, senior and service line leadership to incorporate concepts of safety and standards of care into daily work.

Interfaces with internal and external key stakeholders including other departments, leaders across the organization, and representatives from external agencies / organizations to provide guidance, resolve issues, and / or implement processes and / or solutions??

Evaluates the performance of the department operations, including quality assurance and trends. Makes recommendations to leadership and / or implements operational changes based on findings. Reviews data and / or summary findings with participants, stakeholders, leadership, and / or cross-functional teams.

Identifies opportunities for process improvements and introduction of best practices within the department function.??Participates in organizational process and / or efficiency initiatives as applicable and related to areas of expertise

Drives change by providing centralized development, implementation, and oversight of programs and initiatives designed to improve and support relevant programs.??

Assesses communication and training needs, develops and implements any applicable communication, education, training, on-boarding and / or mentorship within the department. Provides regular communication to stakeholder departments and leaders across the organization. May work with cross-functional teams across multiple departments to develop communication and training materials

Maintains data system integrity and ensures quality assurance measures are followed based on departmental standard operating procedures. May provide ad hoc reporting to support recommendations observed through trend analysis for future planning and enhancements.

Monitors department programs to ensure appropriate governance and program compliance with local, state, and federal laws; accreditation, professional and regulatory agency standards, and licensure requirements.?? Maintains staff and program compliance with organizational policies and procedures.

Demonstrates initiative, resourcefulness, and problem-solving skills in applying a detailed knowledge of the responsibilities, functions, and underlying management structure of the department and of the larger Health System in organizing and prioritizing work, establishing procedures and systems, and ensuring the orderly and timely flow of operations.

Department Specific Duties??

• Responsible for intervention meeting schedules and collaborates with administrative colleagues to coordinate PARS / CORS committee co-chairs and leaders. Develops resources including agendas and identifies participants for intervention meetings in partnership with appropriate stakeholders.
• In conjunction with the PARS / CORS chair, staffs all meetings related to the program. Organizes and follows up on all PARS and CORS interventions.
• Processes all PARS / CORS reports and provide egregious reports to appropriate parties. Coordinates PARS / CORS unnamed list, physician list, uploads and maintains all confidential records related to the PARS / CORS program.
• Partners with leadership to develop key performance metrics for the program, tracks, trends and provides routine reports. Manages highly sensitive data from multiple inputs including management of technical aspect for data exchange.
• Retrieves report from secure message, reviews report, discusses with leadership, and sends reports to be reviewed and distributed.
• Interfaces with internal and external partners / collaborator as well as leaders across the organization.

Qualifications

Education :