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Senior Director Regulatory Affairs - Waltham, United States - Fresenius Kidney Care
Description
Senior Director Regulatory Affairs page is loadedSenior Director Regulatory Affairs
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locations
Waltham, MA, USA
time type
Full time
posted on
Posted 3 Days Ago
job requisition id
R
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.
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.
Maintains and disseminates information and guidance to the field and contributes to, as necessary, keeping current the Regulatory Compliance site on the company intranet.
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.
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
Bachelor's 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.
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.
Pay Transparency Request Form
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.
About Us
Our Work Experience is the combination of everything that's unique about us:
our culture, our core values, our company meetings, our commitment to sustainability, our recognition programs, but most importantly, it's our people.
Our employees are self-disciplined, hard working, curious, trustworthy, humble, and truthful. They make choices according to what is best for the team, they live for opportunities to collaborate and make a difference, and they make us the#1 Top Workplace in the area.
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