Senior Director of Regulatory Affairs
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...
- Rate: Not Specified
- Location: Waltham, US-MA
- Type: Permanent
- Industry: Management
- Recruiter: Fresenius Medical Care Holdings, Inc.
- Contact: Not Specified
- Email: to view click here
- Reference: R0199348
- Posted: 2025-04-03 08:42:14 -
- View all Jobs from Fresenius Medical Care Holdings, Inc.
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