Posted:
4/2/2025, 6:25:20 AM
Location(s):
Waltham, Massachusetts, United States ⋅ Massachusetts, United States
Experience Level(s):
Senior
Field(s):
Legal & Compliance
Workplace Type:
Remote
This is a remote position with 25% travel
This role supports Great Plains & Western Group - must be in CST, MST or PST time zone
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.
If your location allows for pay transparency, please click the link below to request further information on this position.
EOE, disability/veteransWebsite: https://fmcna.com/
Headquarter Location: Waltham, Massachusetts, United States
Employee Count: 10001+
Year Founded: 1996
Last Funding Type: Post-IPO Equity
Industries: Biotechnology ⋅ Health Care ⋅ Medical ⋅ Pharmaceutical