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This is a remote position with 25% travel
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 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
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.
SUPERVISION:
EDUCATION AND REQUIRED CREDENTIALS:
EXPERIENCE AND SKILLS:
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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Full Time
$156k-203k (estimate)
05/14/2024
05/21/2024
DENVER, CO
25 - 50
2010
DAN KNACK
$10M - $50M
The job skills required for Senior Director Regulatory Affairs include Leadership, Initiative, Regulatory Compliance, Collaboration, Project Management, Written Communication, etc. Having related job skills and expertise will give you an advantage when applying to be a Senior Director Regulatory Affairs. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Senior Director Regulatory Affairs. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Senior Director Regulatory Affairs positions, which can be used as a reference in future career path planning. As a Senior Director Regulatory Affairs, it can be promoted into senior positions as a Regulatory Affairs Director that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Senior Director Regulatory Affairs. You can explore the career advancement for a Senior Director Regulatory Affairs below and select your interested title to get hiring information.