Regulatory Affairs Assistant

Regulatory Affairs Assistant

The Regulatory Affairs Assistant is responsible for supporting the development, implementation, and monitoring of Regulatory Affairs programs at VCU Health System. This role ensures that organizational operations align with regulatory requirements and internal policies, rules, and procedures. The Assistant works closely with various departments to maintain regulatory records and prepare and submit documentation. The role is responsible for ensuring executive readiness for regulatory related surveys.

Essential Job Statements

Clinical Staffing Coordination

Develops office guidelines and processes, monitoring and revising processes as needed. Maintains staffing calendar within the department. Triage and assign incoming calls and emails.

Operations Coordination and Support for the Department

Coordinate and support regulatory affairs initiatives across departments. Assist with responding to survey findings and developing mitigation strategies. Monitor compliance with regulatory requirements and internal policies, rules, and procedures. Maintain regulatory affairs records, reports, and entrance documents. Assist in preparing regulatory compliance analysis reports for leadership. Support training programs related to regulatory affairs awareness and compliance. Collaborate with standards owners, safety, security, infection prevention, risk, and other departments to review practices, processes, and the environment to identify compliance. Stay updated on relevant laws, regulations, and best practices in regulatory affairs. Lead the process of maintaining contract compliance and scopes of services. Participate in audits and safety improvements.

Regulatory (Federal and State) Survey Readiness and Preparation

Coordinate specific programmatic activities to support regulatory initiatives, including maintenance of scopes of service, standing orders and protocols, and contract quality reviews. Review survey finding responses for accuracy and completeness. Collaborate with providers, team members, and regulatory agencies during regulatory surveys. Gather detailed responses to regulatory survey findings and submit to regulatory agencies. Ensure compliance with HIPAA, CMS, and other healthcare regulations. Maintain accurate documentation and files in regulatory survey management systems. Assist in the preparation and submission of regulatory documents to regulatory authorities. Provides regulatory survey support, including preparation of survey documents, scheduling conference rooms, coordinating food and logistics, and other essential duties, as needed.

Provides operations support for the department by maintaining the regulatory affairs departmental calendar. Develops and initiates survey guidelines and processes, monitoring and revising processes, as needed. Assist with regulatory affairs to ensure executive readiness for regulatory related surveys. Participate in survey preparation and assist with leading the command center during survey activities. Prepares and maintains files, documentation, spreadsheets, and databases to support Regulatory Affairs department functions, ensuring accuracy and completeness. Review and process purchase requisitions, track expenditures. Educate and support staff on regulatory survey procedures. Assist in audits and regulatory reviews as needed.

Administrative Support

Coordinate specific programmatic activities to support regulatory initiatives, including maintenance of scopes of service, standing orders and protocols, and contract quality reviews. Support the strategic organization and ongoing management of the Regulatory Tracers Program and quality reporting processes.

Miscellaneous Responsibilities

Performs other duties as assigned and / or participates in special projects to support the mission of VCUHS and the department. Assists team members. Accepts alternate assignments, as required, graciously. Provides education to units / departments when requested.

Employment Qualifications

Required Education : Bachelor's Degree in Healthcare Administration, Business, Project Management, or related field from an accredited program

Minimum Qualifications

Years and Type of Required Experience : Minimum of two (2) years of previous administrative work experience in an office setting. Previous experience with or knowledge of CMS, the Joint Commission, or DNV survey preparation. Previous experience with Microsoft Office applications (Excel, Outlook, PowerPoint, etc.) and Adobe Pro.

Other Knowledge, Skills and Abilities Required : Previous experience in a health care setting. Strong written and oral communication skills. Ability to regularly exercise discretion, independent judgement, and decision making. Ability to work independently and within a team environment. Project management and communication with a variety of individuals / entities. Ability to manage multiple projects and meet deadlines in a fast-paced environment. Interpersonal, time management, and organizational skills. Strong attention to detail and excellent organizational skills.

Working Conditions

Periods of high stress and fluctuating workloads may occur. May have periods of constant interruptions.

Physical Requirements

Physical Demands : Lifting / Carrying (0-50 lbs.), Push / Pull (0-50 lbs.), Stoop, Kneel, Squat, Crawling, Climbing, Balance, Bending

Work Position : Sitting, Walking, Standing

Additional Physical Requirements / Hazards

Physical Requirements : Hear alarms / telephone / tape recorder

Hazards : N / A

Mental / Sensory Emotional

Mental / Sensory : Strong Recall, Reasoning, Problem Solving, Hearing, Speak Clearly, Write Legibly, Reading, Logical Thinking

Emotional : Fast paced environment, Able to Handle Multiple Priorities, Able to Adapt to Frequent Change