Senior Director Regulatory Affairs

PURPOSE AND SCOPE:

Manages a field team of regulatory compliance employees and provides regulatory expertise through leadership collaboration development management monitoring analyzing and evaluating the impact of existing trends and new initiatives related to state and federal regulatory activities.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Maintains current/high level knowledge of state and federal regulations applicable to the provision of dialysis services. Pertinent regulations include but are not limited to:

  • Federal Center for Medicare and Medicaid Services (CMS); End Stage Renal Disease (ESRD) Program regulations

  • State Certificate of Need (CON) and licensure regulations

  • Nurse Practice Social Worker Dietitian Practice and State Pharmacy regulations

  • Renal Network - CMS Statement of Work impact

  • Federal Drug Enforcement regulations

  • Health and Human Services Office for Civil Rights (OCR)

• 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 companys corporate and field stakeholders as necessary. Assists in the development and delivery of company responses to regulatory developments.

• Supports as necessary Leaderships 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 departments 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 Leaderships 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

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • This job operates in an office setting. While performing the duties of this job the employee is regularly required to talk and hear. This role routinely and frequently uses a desk and standard office equipment such as computers phones and photocopiers with repetitive motion.
• This position requires approximately 25% to 50% travel.

SUPERVISION:

• May be responsible for the direct supervision of various levels of Regulatory staff.

EDUCATION AND REQUIRED CREDENTIALS:

• RN license
• Bachelors Degree preferred; specialty in healthcare preferred

EXPERIENCE AND SKILLS:

• 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.

Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.