Michelle Ashby
VCU Health System
Bracey,VA
29
years of professional experience
Regulatory affairs professional with comprehensive experience in navigating complex regulatory landscapes and ensuring compliance. Strong focus on team collaboration and achieving results, with adaptable approach to changing needs. Skilled in regulatory strategy, risk assessment, and policy development. Valued for reliability, analytical mindset, and effective communication in high-stakes environments.
Experienced with regulatory compliance, risk management, and team leadership. Utilizes in-depth knowledge of industry standards to drive compliance and foster culture of adherence. Track record of implementing regulatory strategies and ensuring successful audits.
Work History
Quality, Safety & Regulatory Manager
6 Years 5 Months- Coordinated quality initiatives for medical and surgical oncology, ensuring adherence to regulatory standards.
- Collaborated with teams to ensure adherence to privacy regulations and compliance standards
- Facilitated medical staff quality improvement meetings, promoting best practices and enhancing patient care protocols.
- Directed regulatory compliance programs to align policies with changing federal, state, and industry requirements.
- Reviewed submissions, licenses, and filings for accuracy, completeness, and timely agency delivery.
- Interpreted new regulations and translated requirements into internal procedures and control updates.
- Coordinated cross-functional teams to resolve compliance gaps and support audit readiness.
- Monitored regulatory changes, assessed business impact, and communicated actionable guidance to leadership.
- Maintained documentation, records, and correspondence to support inspections, inquiries, and reporting obligations.
- Advised stakeholders on risk mitigation strategies and improved consistency in regulated processes.
- Conducted thorough reviews of technical documentation to ensure alignment with regulatory standards.
- Contributed significantly to the organization's reputation for regulatory excellence by maintaining a strong track record of compliance and successful audits.
- Reduced risk exposure by proactively identifying potential compliance gaps and initiating appropriate measures.
- Developed strategies to maintain ongoing compliance as new regulations were introduced or updated, ensuring continuous adaptability.
- Managed a successful audit, addressing all findings and implementing corrective actions in a timely manner.
- Leveraged strong relationships with regulatory agencies for expedited approvals during critical timelines.
- Performed and documented quality control checks to maintain compliance with company initiatives.
Interim Director Home Health & Hospice
2 Years 6 Months- Delivered quality nursing care to diverse patient populations in home settings using evidence-based practice and problem-solving skills
- Collaborated with interdisciplinary team members to achieve positive patient outcomes and meet care goals
- Resource nurse for the department as extensive home health experience
- Preceptor on unit and participated in Quality Assurance Performance Improvement committee on unit
- Directed cross-functional initiatives to align operations with organizational goals and priorities.
- Led staff development efforts to strengthen performance, accountability, and succession planning.
- Evaluated business processes and implemented improvements to increase efficiency and quality.
- Collaborated with senior stakeholders to resolve issues and guide long-term planning.
- Monitored compliance requirements and reinforced adherence to internal standards and regulations.
- Drove decision-making through performance reviews, operational analysis, and leadership recommendations.
- Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
- Established a culture of continuous improvement by fostering open communication channels and empowering employees to voice their ideas.
- Strengthened internal controls by reviewing existing policies and procedures, ensuring compliance with regulatory requirements.
- Proactively identified potential risks and implemented mitigation strategies to minimize negative impacts on projects or business operations.
- Evaluated employee performance objectively using established metrics, leading to fair compensation adjustments based on meritocracy principles.
Clinical Coordinator RN
3 Years 6 Months- Delivered quality nursing care to diverse public health patients throughout their lifespan
- Trained and supervised nursing and unlicensed assistive staff to ensure high standards of care
- Developed and maintained community contractual relationships to address holistic patient needs
Director of Clinical Services
2 Years 6 Months- Established and nurtured referral source relationships in community to enhance patient access to services
- Trained and supervised visiting staff to ensure high-quality patient care and compliance with clinical standards
- Conducted initial assessments and reassessments to ensure quality patient care.
- Developed, maintained, and updated policies and procedures related to clinical practice to ensure alignment with best practices
- Directed clinical service operations, aligning staffing, workflows, and patient care standards across departments.
- Led interdisciplinary teams to improve care coordination, documentation accuracy, and service delivery consistency.
Director of Nursing
1 Year- Supervised visiting staff to ensure quality care delivery while instructing new tasks.
- Perform initial assessments and reassessments to ensure all patient needs are met
- Ensured compliance with agency, state and federal laws to uphold operational integrity
- Developed and maintained relationships with community vendors to facilitate resource access and support
- Directed clinical operations to ensure quality home care services and regulatory compliance.
- Oversaw patient assessments, care plans, and ongoing service coordination for continuity of care.
Continuous Quality Improvement Coordinator
1 Year- Assures agency compliance with ACHC standards, state and federal laws and regulations
- Trained new staff on OASIS documentation, ensuring adherence to Medicare and Medicaid guidelines
- Developed and updated policies and procedures for QI/QA functions.
- Perform initial assessments and reassessments with plan of care development
- Oversaw daily operations of licensed, unlicensed, and administrative staff to ensure compliance with agency policies.
- Directed nursing operations, ensuring compliant in-home care delivery and consistent clinical standards.
- Supervised caregivers and nursing staff, reinforcing client safety, documentation accuracy, and care quality.
Registered Nurse
8 Years- Performed contractual nursing duties on a prn basis, including skilled home care, non-skilled supervisory visits, and developing and maintaining home community relationships.
- Coordinated continuous quality improvement initiatives across clinical and operational workflows.
- Assessed patient conditions and prioritized nursing interventions across acute and chronic care settings.
- Coordinated interdisciplinary care plans, aligning treatments with physician orders and patient needs.
Registered Nurse
1 Year- Conducted inmate assessments and delivered health care for emergent and chronic needs
- Executed medication administration and conducted medical testing consistently.
- Facilitated therapeutic conversations with mental health population under suicide watch
- Administered medications and monitored responses, maintaining strict adherence to safety protocols.
Education
Bachelor of Science - Nursing
- Honor Society of Nursing
Skills
Regulatory research
Risk management
Clinical development
Attention to detail
Critical thinking
Global regulatory compliance
Timeline
Quality, Safety & Regulatory Manager
VCU Health System
06.2020 - CurrentRead More
Interim Director Home Health & Hospice
VCU Health System
12.2017 - 06.2020Read More
Clinical Coordinator RN
Granville Vance Public Health
06.2014 - 12.2017Read More
Director of Clinical Services
High Calling Home Care
06.2012 - 12.2014Read More
Director of Nursing
Visiting Angels Home Care
08.2011 - 08.2012Read More
Continuous Quality Improvement Coordinator
Home Health & Hospice of Person County
01.2007 - 01.2008Read More
Registered Nurse
Interim HealthCare
01.1999 - 01.2007Read More
Registered Nurse
Federal Bureau Of Prisons
01.1998 - 01.1999Read More
Grand Canyon University
Bachelor of Science from Nursing
Read More