Fresenius Medical Care · 1 day ago
Senior Director Regulatory Affairs
Waltham, MA
Full-time
Onsite
Director/Executive
$155K/yr - $194K/yr
7+ years expFresenius Medical Care is a leading provider of dialysis services, and they are seeking a Senior Director of Regulatory Affairs to manage a field team and provide regulatory expertise. The role involves maintaining knowledge of state and federal regulations, evaluating their implications for company operations, and collaborating with various departments to ensure compliance.
BiotechnologyHealth CareMedical Device
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
Qualification
Required
RN license
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
Preferred
Bachelor's Degree preferred; specialty in healthcare preferred
Benefits
Medical, dental, and vision insurance
A 401(k) with company match
Paid time off
Parental leave
Potential for performance-based bonuses depending on company and individual performance
Company
Fresenius Medical Care
Fresenius Medical Care is a healthcare company that provides dialysis treatment for those with chronic kidney diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$758.43M2025-11-17Post Ipo Debt· $579.5M
2025-07-21Post Ipo Equity· $4.86M
2020-02-25Post Ipo Equity· $6.07M
Leadership Team
Helen Giza
Chief Executive Officer
Joseph Turk
CEO of Care Enablement and Member of the Management Board of Fresenius Medical Care
Recent News
2025-11-19
Company data provided by crunchbase