Director of Regulatory Affairs

Position Summary

The Director of Regulatory Affairs is responsible for overseeing medical records (HIM), referrals, compliance, and accreditation to ensure adherence to federal, state, and local regulations. This role ensures that all departments operate in alignment with HRSA, AAAHC, HIPAA, OSHA, and other regulatory and accreditation bodies. The Director provides leadership in regulatory strategy while fostering a culture of compliance and continuous quality improvement.

Essential Duties & Functions

HIM and Referral Management

• Monitor and manage the integrity of medical records (HIM) and electronic health records (EHR), ensuring adherence to HIPAA, the HITECH Act, and other applicable laws.
• Oversee the proper documentation, storage, and timely completion of charts, collaborating closely with clinical, operational, and IT teams.
• Collaborate with clinical, operational and IT teams to improve workflows related to HIM and referrals.
• Oversee referrals processing, ensuring efficient and compliant coordination of patient care.

Compliance & Accreditation

• Prepare for and assist in audits and accreditation reviews by working alongside the Chief Regulatory Officer.
• Provide training and guidance to staff on regulatory, HIPAA, and compliance requirements
• Ensure compliance with federal, state and local accrediting bodies. Collaborate with various departments to streamline workflows and resolve any regulatory or compliance issues.
• Develop and implement policies and procedures to maintain regulatory readiness at all times.
• Collaborate with various departments to streamline workflows and resolve any regulatory or compliance issues.
• Stay informed about changes in healthcare regulations and best practices, adapting strategies and processes to sustain a culture of continuous quality improvement.
• Provide regular reports and updates to senior leadership on regulatory activities, compliance status, and areas requiring attention or improvement.
• Other duties as assigned by CRO.

Required Education, Certifications, Licenses, & Training

• Bachelor's degree in nursing (RN), Healthcare Administration, or a health care related field (master's preferred).
• A strong understanding of compliance and regulatory standards

Required Years of Experience

• Minimum 2-3 years in a leadership role.
• 1-2 years' experience in working with electronic health record (EPIC preferred)
• Minimum 3 years of working in a healthcare setting.

Required Knowledge, Skills, and/or Abilities

• Ability to navigate and enter data in an electronic health records system
• Strong analytical and reporting capabilities.
• Strong communication skills, both orally and written
• Ability to develop policies, lead audits and manage regulatory documentation.