Fresenius Medical Care
Senior Director Regulatory Affairs
Fresenius Medical Care, Waltham, Massachusetts, United States, 02254
Overview
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. Responsibilities
Maintains current/high level knowledge of state and federal regulations applicable to the provision of dialysis services, including but not limited to federal CMS ESRD program regulations, state 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, and Health and Human Services OCR. Evaluates and defines federal and state regulations and regulatory developments in terms of applicability and implications for company operations, policies, procedures, and initiatives; makes recommendations to Leadership; clarifies and communicates regulatory developments to corporate and field stakeholders; assists in developing and delivering company responses to regulatory developments. Supports Leadership's collaboration with Corporate Compliance, Clinical Services, Operations, Quality, Education, and Corporate Law to develop and implement programs, policies, and initiatives consistent with regulatory requirements. Assesses facilities likely to be surveyed and determines which facilities require mock surveys using data-based models. Manages, trains, and supervises Regulatory staff in day-to-day activities including scheduling and completing mock surveys, assisting facility management in correcting deficient practices, and following up on facility compliance with plans and corrections. Supports facilities by leading the development of detailed and timely plans of corrections in response to state and federal regulatory surveys, including Immediate Jeopardy and Condition findings. Collaborates in developing processes and systems to track and analyze survey outcomes and designs related reports for routine distribution to appropriate corporate and field personnel. Collaborates with Leadership in developing, implementing, and managing the department's long-range goals, initiatives and budgets; develops financial implications related to ongoing responsibilities and 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 keeps current the Regulatory Compliance site on the company intranet. Maintains liaison and collaborates with state regulatory agencies; supports Leadership 20s 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 are representative of those encountered while performing the essential functions of this job. Reasonable accommodations may be made for individuals with disabilities. This job operates in an office setting. The employee regularly talks and hears, and uses a desk and standard office equipment with repetitive motion. Travel approximately 25% to 50%. 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 of related experience in a management position in or with regulatory agencies and the 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 crisis management, 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 The rate of pay for this position will depend on the successful candidate’s work location and qualifications, including relevant education, work experience, skills, and competencies. Rate: $116,400 - $194,000 Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave and potential for performance-based bonuses depending on company and individual performance Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws. EOE, disability/veterans
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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. Responsibilities
Maintains current/high level knowledge of state and federal regulations applicable to the provision of dialysis services, including but not limited to federal CMS ESRD program regulations, state 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, and Health and Human Services OCR. Evaluates and defines federal and state regulations and regulatory developments in terms of applicability and implications for company operations, policies, procedures, and initiatives; makes recommendations to Leadership; clarifies and communicates regulatory developments to corporate and field stakeholders; assists in developing and delivering company responses to regulatory developments. Supports Leadership's collaboration with Corporate Compliance, Clinical Services, Operations, Quality, Education, and Corporate Law to develop and implement programs, policies, and initiatives consistent with regulatory requirements. Assesses facilities likely to be surveyed and determines which facilities require mock surveys using data-based models. Manages, trains, and supervises Regulatory staff in day-to-day activities including scheduling and completing mock surveys, assisting facility management in correcting deficient practices, and following up on facility compliance with plans and corrections. Supports facilities by leading the development of detailed and timely plans of corrections in response to state and federal regulatory surveys, including Immediate Jeopardy and Condition findings. Collaborates in developing processes and systems to track and analyze survey outcomes and designs related reports for routine distribution to appropriate corporate and field personnel. Collaborates with Leadership in developing, implementing, and managing the department's long-range goals, initiatives and budgets; develops financial implications related to ongoing responsibilities and 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 keeps current the Regulatory Compliance site on the company intranet. Maintains liaison and collaborates with state regulatory agencies; supports Leadership 20s 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 are representative of those encountered while performing the essential functions of this job. Reasonable accommodations may be made for individuals with disabilities. This job operates in an office setting. The employee regularly talks and hears, and uses a desk and standard office equipment with repetitive motion. Travel approximately 25% to 50%. 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 of related experience in a management position in or with regulatory agencies and the 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 crisis management, 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 The rate of pay for this position will depend on the successful candidate’s work location and qualifications, including relevant education, work experience, skills, and competencies. Rate: $116,400 - $194,000 Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave and potential for performance-based bonuses depending on company and individual performance Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws. EOE, disability/veterans
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