Regulatory Affairs Director

Johns Hopkins HealthCare LLC; Washington (District of Columbia); On-site; USD 113,000 - 177,000; Full time

Benefits offered by this job

Tuition assistance

403(b) retirement savings

Health coverage

Dental coverage

Vision coverage

Prescription coverage

Disability insurance

Life insurance

Paid time off

Holidays

Job summary

Johns Hopkins Health System in Washington, DC seeks a Director of Regulatory Affairs to lead strategic regulatory programs, ensure federal, state, and local compliance, and align accreditation activities with patient safety and quality goals.

You will oversee survey readiness, act as liaison with regulators, develop policies and education, and drive enterprise-wide improvements with senior leadership.

Qualifications

• Master's degree preferred in healthcare, public health, nursing, health administration, or related field.
• Bachelor's degree in regulatory affairs, life sciences, or a related field required.
• 10+ years experience in regulatory affairs or a related field.
• 2-5 years of prior leadership/management experience preferred.
• Experience with performance improvement methodologies and quality improvement tools.
• Demonstrated experience leading regulatory surveys and readiness programs required.

Responsibilities

• Develops and leads enterprise-wide regulatory compliance and readiness strategy aligned with organizational priorities.
• Oversees a continuous regulatory readiness program, including tracer activities, audit processes, data analysis, and education; chairs or co-chairs readiness committees.
• Directs all regulatory survey activities (e.g., TJC, CMS, DOH), including preparation, command center operations, surveyor coordination, and post-survey response.
• Coordinates and oversees mock surveys and external consulting engagements to assess readiness and drive performance improvement.
• Collaborates with stakeholders to develop, implement, and monitor corrective action plans, ensuring sustained compliance.
• Provides oversight of accreditation, certification, and licensure processes across applicable entities.
• Monitors and interprets evolving regulatory requirements and translates them into actionable policies, procedures, and workflows.
• Serves as primary liaison with regulatory agencies; manages communications, submissions, and responses to inquiries or findings.
• Collaborates on investigation and response to patient complaints received from external regulators and accreditors.
• Ensures maintenance of regulatory systems, portals, and documentation repositories, including submission tracking and audit readiness.
• Provides regulatory insight and risk analysis to senior leadership to inform strategic decision-making.
• Leads or partners on interdisciplinary initiatives to improve compliance, patient safety, and quality outcomes.

Skills

Regulatory affairs

Leadership

Quality improvement

Regulatory surveys

Education

Master's degree

Bachelor's degree

Job description

Job Details

Location: Johns Hopkins Health System, Washington, DC 20001

Schedule: Day Shift

Employment Type: Full Time

This is a fully onsite position which will be supporting Sibley Memorial Hospital which is a non-profit, full service 318 bed acute care community hospital serving the Washington, DC area. Sibley offers medical, surgical, intensive care, obstetric, oncology, orthopedic and skilled nursing inpatient services, as well as a 24-hour Emergency Department. Sibley's campus is also home to Grand Oaks, an assisted living residence; a medical building with physician offices and ambulatory surgery and imaging centers; and the new patient tower with 200 spacious, private rooms.

The Director of Regulatory Affairs is responsible for leading the strategic planning, implementation, and continues evaluation of regulatory compliance programs to support patient safety, quality outcomes, and sustained readiness. Ensures organizational compliance with federal, state, and local regulatory requirements, including accreditation and certification standards (e.g., TJC, CMS, DOH).

Provides enterprise-level oversight of regulatory readiness infrastructure, including survey planning and execution (announced and unannounced), regulatory submissions, and corrective action management. Interprets and operationalizes regulatory requirements into policies, workflows, and education. Serves as the key liaison with regulatory agencies and as a strategic advisor to executive leadership, while functioning as a subject matter expert and consultant across the organization.

Essention Functions

• Develops and leads enterprise-wide regulatory compliance and readiness strategy aligned with organizational priorities.
• Oversees a continuous regulatory readiness program, including tracer activities, audit processes, data analysis, and education; chairs or co-chairs readiness committees.
• Directs all regulatory survey activities (e.g., TJC, CMS, DOH), including preparation, command center operations, surveyor coordination, and post-survey response.
• Coordinates and oversees mock surveys and external consulting engagements to assess readiness and drive performance improvement.
• Collaborates with stakeholders to develop, implement, and monitor corrective action plans, ensuring sustained compliance.
• Provides oversight of accreditation, certification, and licensure processes across applicable entities.
• Monitors and interprets evolving regulatory requirements and translates them into actionable policies, procedures, and workflows.
• Serves as primary liaison with regulatory agencies; manages communications, submissions, and responses to inquiries or findings.
• Collaborates on investigation and response to patient complaints received from external regulators and accreditors.
• Ensures maintenance of regulatory systems, portals, and documentation repositories, including submission tracking and audit readiness.
• Provides regulatory insight and risk analysis to senior leadership to inform strategic decision‑making.
• Leads or partners on interdisciplinary initiatives to improve compliance, patient safety, and quality outcomes.

Education

• Master's Degree in healthcare, public health, nursing, health administration, or related field preferred
• Bachelor's Degree in regulatory affairs, life sciences, or a related field required

Experience

• 10+ years experience in regulatory affairs or a related field required
• 2-5 years of prior leadership/management experience preferred
• Experience with performance improvement methodologies and quality improvement tools
• Demonstrated experience leading regulatory surveys and readiness programs required

Licensure and Certification

• Certified Professional in Healthcare Quality (CPHQ) preferred
• Certified Joint COmmission Professional or equivalent regulatory certification preferred

What We Offer

• Tuition assistance
• Dependent college tuition program
• 403(b) retirement savings
• Health coverage
• Dental coverage
• Vision coverage
• Prescription coverage
• Disability insurance
• Life insurance
• Paid time off
• Holidays

Salary Range: Minimum 113,048.00/annually - Maximum 176,696.00/annually. Compensation will be commensurate with equity and experience for roles of similar scope and responsibility. In cases where the range is displayed as a $0 amount, salary discussions will occur during candidate screening calls, before any subsequent compensation discussion is held between the candidate and any hiring authority.

The Hospital reserves the right to modify employee schedules as needed.

We are committed to creating a welcoming and inclusive environment, where we embrace and celebrate our differences, where all employees feel valued, contribute to our mission of serving the community, and engage in equitable healthcare delivery and workforce practices.

Johns Hopkins Health System and its affiliates are drug-free workplace employers.

Johns Hopkins Health System and its affiliates are an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity and expression, age, national origin, mental or physical disability, genetic information, veteran status, or any other status protected by federal, state, or local law.