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Senior Director of Regulatory Affairs

Posted about 20 hours agoViewed

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💎 Seniority level: Director, 7+ years

📍 Location: United States, CST, MST, PST

🔍 Industry: Dialysis

🏢 Company: fme👥 251-500Cloud Data ServicesConsultingBusiness IntelligenceBusiness DevelopmentSoftware Engineering

🗣️ Languages: English

⏳ Experience: 7+ years

🪄 Skills: LeadershipProject ManagementPeople ManagementStrategic ManagementCommunication SkillsAnalytical SkillsCollaborationMicrosoft ExcelCustomer serviceAgile methodologiesAttention to detailOrganizational skillsPresentation skillsTime ManagementWritten communicationComplianceCoachingInterpersonal skillsProblem-solving skillsMS OfficeNegotiation skillsVerbal communicationReportingTrainingBudgetingCross-functional collaborationRisk ManagementTeam managementFinancial analysisChange Management

Requirements:
  • 7+ years' related experience in a management position either in, or with, regulatory agencies and dialysis industry
  • Strong management skills with the ability to lead cohesive and productive teams and project management experience.
  • Proven project and staff leadership/management skills including, but not limited to: management of crisis or unforeseen issues, communication, customer service, performance management and continuous quality improvement.
  • Strong interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact.
  • Excellent oral and written communication skills.
  • RN license
Responsibilities:
  • Maintains current/high level knowledge of state and federal regulations applicable to the provision of dialysis services.
  • Evaluates and defines federal and state regulations and regulatory developments in terms of applicability and implications relevant to the company operations, policies, procedures and initiatives, and makes recommendations to Leadership.
  • Clarifies and communicates regulatory developments, new regulations, and changing requirements and their implications to the company's corporate and field stakeholders as necessary.
  • Assists in the development and delivery of company responses to regulatory developments.
  • Supports, as necessary, Leadership's collaboration with Corporate Compliance, Clinical Services, Operations, Quality, Education, and Corporate Law departments relative to the development and implementation of programs, polices, and initiatives which are consistent with regulatory requirements.
  • Assesses facilities that are likely to be surveyed and which of those facilities require mock surveys using data-based models.
  • Manages, trains and supervises the responsibilities and day-to-day activities of Regulatory staff in the execution of their duties which include, but are not limited to: scheduling and completing mock surveys, assisting facility management in the correction of deficient practices and/or following up with facility compliance of plans and corrections.
  • Supports facilities by assuming a lead role in the development of detailed and timely plans of corrections in response to state and federal regulatory surveys in the event of Immediate Jeopardy and Condition level findings.
  • Collaborates in the development of processes and systems to better track and analyze survey outcomes and assists in designing related reports for routine distribution to appropriate corporate and field personnel.
  • Collaborates to support Leadership in the development, implementation and management of the department's long-range goals, outstanding and new initiatives and budgets; the development of financial implications related to ongoing responsibilities, activities and the development and implementation of initiatives to enhance regulatory compliance and to correct serious incidents of noncompliance.
  • Supports the implementation of corporate quality goals and action plans.
  • Maintains and disseminates information and guidance to the field and contributes to, as necessary, keeping current the Regulatory Compliance site on the company intranet.
  • Maintains liaison and collaborates, whenever possible, with state regulatory agencies; supports Leadership's similar relationships with federal regulatory agencies.
  • Develops and manages the implementation of and reports on the progress of special projects as assigned.
  • Performs other related duties as assigned
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