Regulatory Affairs Director

The Center for Elders’ Independence is a PACE (Program of All-Inclusive Care for the elderly) organization (PO) that uses an interdisciplinary team approach for care planning and implementing purposeful high quality, affordable, and integrated health care services to the elderly.  Our elderly meet PACE requirements as prescribed by CMS and are referred to as participants.  Our PO includes Adult Day Health Centers and primary care clinics, promoting participant autonomy, quality of life and the ability for individuals to live in their communities

THE POS I TION : The Director of Regulatory Affairs will develop and execute healthcare policy analysis and s trategic oversight of CEI’s regulatory strategy to ensure compliance with federal and California PACE requirements ( Centers for Medicare & Medicaid Services (CMS) and California Department of Health Care Services (DHCS) ). This D irector provides strategic guidance, supports compliance program management, and serves as the primary liaison with government agencies, particularly CMS and DHCS . This leader will manage regulatory submissions, guide cross ‑ functional teams through complex healthcare policy and regulatory matters, and support audits, inspections, and ongoing regulatory reporting. The role requires deep experience with healthcare policy , PACE federal and state regulatory frameworks, strong project and stakeholder management skills, and proven leadership in healthcare regulatory / compliance environments .

DUTIES AND RESPONSIBILITIES :

• Regulatory Affairs : Develop and implement regulatory strategies that support CEI’s PACE program growth and ongoing compliance with CMS and DHCS requirements.   Act as the primary point of contact for CMS and state agencies , which involves managing relationships, responding to inquiries, and representing the PACE organization during audits or investigations . Lead preparation, submission, tracking, and maintenance of PACE applications, amendments, notices, and other regulatory filings to CMS and DHCS.   Partner with legal counsel, external compliance consultants, and the Compliance Officer to coordinate filings, audits, and regulatory responses.
• Policy I nterpretation and S trategy : Monitor, interpret and communicate new federal and state regulations, policy changes, and guidance documents to determine their impact on PACE operations. Assess operational impact and develop and communicate a regulatory strategy to senior leadership to implement required changes.
• Compliance P rogram M anagement : Implement and m onitor effective compliance program elements . C reat e policies and procedures, ensur e annual risk assessments are performed, and manag e an annual auditing plan s .
• Risk A ssessment and M itigation : Identify and assess potential compliance risks and develop strategies to mitigate them. This includes resolving any instances of non-compliance and implementing corrective action plans. Conduct regulatory risk assessments; identify, escalate, and mitigate regulatory risks in collaboration with the General Counsel, Compliance Officer, and operational leaders.  Review marketing and promotional materials for regulatory compliance.  Oversee annual compliance reviews, audits, testing, and monitoring of internal controls related to PACE operations and regulatory filings.
• Process Improvement : Design, enhance, and maintain compliance workflows, systems, and internal controls to support efficient regulatory operations .  Represent CEI on multidisciplinary continuous improvement projects and ensure regulatory perspectives are integrated into organizational strategy
• Training and E ducation : Draft, update, and maintain policies, procedures, and guidance documents; provide regulatory education across departments.  Create and deliver training programs to ensure all staff and contractors understand and comply with regulatory requirements. This fosters a culture of compliance throughout the organization.

QUALIFICATIONS : Deep, working knowledge of healthcare policy, PACE federal and state regulatory frameworks, including CMS and DHCS requirements.

The above job description is intended to communicate the general function of the mentioned position and by no means shall be considered an exhaustive or complete outline of the specific tasks and functions that will be required.  CEI reserves the right to change job descriptions, site assignments, and or work hours as required by the needs of the program.  All employees are expected to perform their duties within their ability as required by the job and / or as requested by management.

Center for Elders’ Independence is a PACE (Program of All- Inclusive Care for the Elderly) organization that uses an interdisciplinary team approach to care planning and care implementation for the purpose of providing high quality, affordable, integrated health care services to the elderly, including an Adult Day Health Center, and promoting autonomy, quality of life and the ability of individuals to live in their communities. Unlike other healthcare plans, CEI is not a "fee-for-service" plan. It is a “capitation” healthcare plan. CEI is paid a set amount for each person enrolled in our program, whether or not that individual seeks care. We are a growing company that offers stability and continues to thrive.