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FMS VP Regulatory Affairs

Job ID: 14000EB3

Job Location: Waltham, MA

JOB GRAPH

The chart below shows a general breakdown of time spent performing typical tasks for this role.


PURPOSE AND SCOPE:


Guides patient care standards by providing overall strategic direction and management of the FMS Regulatory Affairs Department ensuring the appropriate provision of support and guidance for all FMS operations and initiatives while adhering to the FMCNA Compliance Program and all regulatory and FMS policy requirements. Acts as the FMS Division regulatory expert; monitoring, analyzing and evaluating the impact of trends and initiatives related to state and federal regulatory activities; and overseeing the associated communications to the appropriate personnel for implementation.



Supports FMCNA's mission, vision, values and customer service philosophy.



DUTIES I ACTIVITIES:



CUSTOMER SERVICE:



  • Responsible for driving the FMS culture though customer service standards.
  • Accountable for outstanding customer service to all external and internal customers, including patients, staff, physicians, Business Unit and Corporate personnel, and state and federal agencies.
  • Develops and maintains effective relationships through effective and timely communication with all customers.
  • Takes initiative and action to respond, resolve and follow up regarding customer service issues with all customers in a timely manner.

QUALITY TRAINING:



  • Evaluate and define federal and state regulations and regulatory developments in terms of applicability and use for Fresenius Medical Services. Clarify and communicate to appropriate FMS personnel the pertinent regulations which include, but are not limited to:


-Federal Center for Medicare and Medicaid Services (CMS) End Stage Renal Disease (ESRD) Program regulations;


-Health and Human Services Office for Civil Rights (OCR), and state Certificate of Need (CON) and licensure regulations;


-Nurse Practice, Social Worker, Dietitian Practice Acts and State Pharmacy regulations.



  • Analyze and assess the federal/state regulatory impact of business development initiatives, such as, acquisitions, divestitures, and mergers of facilities and new programs such as Chronic Kidney Disease Services (CKD), Acute Dialysis Services, and Home Therapies)
  • Support the implementation of corporate quality goals and action plans in collaboration with the FMS Vice President of Clinical Quality Management, Business Unit Vice Presidents of Quality, Business Unit Directors of Training, and the Chief Medical Officer in order to achieve established FMS quality standards.
  • Develop and implement relevant educational materials for Clinical Managers and operational managers: coordinate and participate in staff education and training programs as necessary. Ensure the distribution of educational material as needed.
  • Collaborate with the Corporate Compliance and Corporate Law Departments to support the development and implementation of programs, policies and procedures based on best practices and regulatory requirements.
  • Ensure the delivery of quality patient care through collaboration with FMS corporate and business unit staff throughout the FMS organization.
  • Collaborate with the Vice President of Clinical Quality Management to provide support and direction relative to the achievement FMS quality standards.
  • Collaborate with the Vice President of Human Resources and Organizational Development and FMS field management to communicate applicable federal and state regulatory requirements and related FMS standards and processes to the pertinent training departments.
  • Ensure compliance with all pertinent data collections and auditing activities.

OPERATIONS



  • Provide input regarding the strategic direction of the FMS Regulatory Affairs Department.
  • Establish and maintain a close working relationship with appropriate external regulatory agencies:


> Develops responses to state and regulatory agencies regarding FMS policies and procedures and includes rationale and references supporting our practices and standards where applicable.



  • Track and analyze regulatory developments and survey outcomes and report these to Senior Vice President of Operations, Chief Medical Officer, Vice President of Quality Management and other senior management for action as is determined as necessary.
  • Assist with all aspects of the development and implementation of Collective actions in response to external regulatory survey findings.
  • Assist with department long-range goal development and budget preparation by understanding and providing input regarding profit and loss management as it pertains to regulatory outcomes and corrective actions.
  • Assess the regulatory impact of new businesses such as Chronic Kidney Disease (CKD), Acute Dialysis Services, and Skilled Nursing Facilities (SNFs); and provide direction to business leaders regarding applicable federal/state regulatory allowances and prohibitions.
  • Maintain current knowledge regarding health-care related regulatory, compliance and dialysis industry issues. Take action as would be appropriate.
  • Direct and coordinate regulatory communications throughout the FMS organization.
  • Develop annual updates to the Regional Quality Manager Facility Audit Tool and any other related tool.
  • Prepare related instructions and documents. Ensure distribution and communication as needed.

OTHER:


• Other 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.


Day to day work includes desk and personal computer work and interaction with Corporate, Business Unit Area and facility managers. The position requires travel to the Business Units. Travel to regional, Business Unit and Corporate meetings will be required. The work environment is characteristic of an office and health care facility with air temperature control and moderate noise levels. May be exposed to infectious and contagious diseases/materials.


EDUCATION


  • Bachelor's degree in healthcare or related field required.

  • Masters degree in healthcare or other applicable graduate degree preferred.

EXPERIENCE AND REQUIRED SKILLS


  • At least 10 years experience in working for, or with, regulatory agencies.

  • At least 5 years experience in the dialysis industry.

  • Demonstrated leadership skills including, but not limited to communication, customer service, performance management and continuous quality improvement.

  • Strong verbal and written communication skills.

  • Strong personal computer skills.

EO/AA Employer: Minorities/Females/Veterans/Disabled






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Greg C.-  Manager, Regulatory AffairsStacy A. - Regulatory Affairs Associate II - Devices

Greg C.- Manager, Regulatory Affairs

At Fresenius, we improve the lives of our patients through innovation and high quality dialysis solutions. We are a team of very highly capable professionals who continuously demonstrate a high confidence in our operational strategy, and we're enjoying a lot of success because of that.

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