Well-organized and diligent Regulatory Affairs Specialist adept at coordinating and tracking regulatory-related actions. Highly successful at keeping on top of changes in requirements to maintain flawless compliance. Offering 30 experience in transplant and looking for a challenging new role.
Experienced administrative professional knowledgeable about registrations, audits, inspections and other transplant industry regulatory proceedings. Special skill in managing complex documentation, reports and data for regulatory reporting and compliance. Exceptional public relations skills.
Skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Articulate and personable with exceptional data analysis, report writing and recordkeeping abilities.
Skills
Data verification
Transplant compliance
Transplant statutes understanding
Regulatory Policies
Technical Documentation with XynQAPI
Regulatory Agency Applications UNOS and CMS
Project Management
Audits
Strategic Clinical Planning
Training
Improvement initiatives
Business administration
Key Performance Indicators
Technology integration / computer savvy
Work History
06/2019 to Current
Quality and Regulatory Affairs Specialist Allegheny General Hospital AHN – City, STATE,
Performed transplant audits for all organs for compliance with regulatory compliance.
Prepared for transplant surveys by Centers for Medicare and Medicaid.
Responsible for policy reviews and updates for transplant.
Prepared for transplant quality and performance improvement (QAPI) meetings quarter.
Assisted in preparing for reporting transplant outcomes and updates to AHN Board and PIOC
Assisted in preparing for presentations for Morbidity and Mortality Conferences for transplant events.
Reviewed RL solutions for all transplant events to document and report up to staff
Worked closely with Directors of Abdominal and Heart Transplant on Quality and Process Improvements.
Site Administrator for United Network for Organ Sharing (UNOS).
Complete requests for information (RFI's) from contracting agencies.
Complete and submit applications for key change of personnel changes to UNOS.
03/2008 to 06/2019
Project Coordinator, Quality and Compliance University Of Pittsburgh Medical Center – City, STATE,
Oversight for the development, coordination, implementation and evaluation of quality improvement and patient safety initiatives.
Leadership role in monitoring and maintaining compliance with requirements of external agencies specifically related to transplant (CMS, UNOS, NKR).
Organized and held living donor safety meetings to ensure donor are receiving quality care when donating an organ.
Organized and presented at the monthly Quality and Performance Improvement (QAPI) meetings.
03/2006 to 06/2008
Administrative Transplant Coordinator University Of Pittsburgh Medical Center – City, STATE,
Office operations including payroll and special projects.
Responsible for completion of United Network for Sharing (UNOS) applications for key personnel changes.
Responsible for updates to regulatory requirements as they related to transplant policies and procedures.
Completed Request for Information (RFI's) from contracting agencies.
Site Administrator for UNOS
Updated and reviewed quality performance improvement processes for seven transplant programs.
Completed internal auditing and review of medical records for compliance.
Prepared dashboards for all audit results to be presented to various levels of organization.
Reviewed and assisted in development and updates of policies to ensure regulatory compliance.
Educated transplant staff on policy updates and regulatory compliance.
Ambassador for Organ Donor and Transplant Alliance and facilitated educational webinars for nursing recertification.
09/1990 to 03/2006
Coordinator Transplant Multinational Services Children's Hospital Of Pittsburgh – City, STATE,
Managed daily operations of transplant office and clinic.
Interviewed potential staff and assisted in annual reviews for transplant administrative staff.
Identified and resolved problems to ensure patient satisfaction.
Worked with senior management to ensure organizational and operation budgets were met.
Made sure policy and procedures adhered to compliance requirements of regulatory agencies.
Responsibilities included payroll, preparation of manuscripts, abstracts, presentations and special projects.
Responsible for Director and Chief of transplant meetings and travel arrangement.
Education
Expected in 02/2022
Master of Science: Masters of Health Care Administration Walden University - Minneapolis, MN, GPA:
Expected in 12/2019
Master of Science: Business Administration Aspen University - Phoenix, AZ, GPA:
Expected in 05/2008
Associate of Science: Business Management Community College of Allegheny County - Pittsburgh, PA, GPA:
Expected in 06/1980
High School Diploma: Penn Hills Senior High School - Penn Hills, PA, GPA:
Expected in 06/1980
Certificate : Certified Medical Secretary Forbes Road East Area Vocational Technical School - Monroeville, PA, GPA:
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