Prepare and submit documents, including IDEs, PMAs, and Design Dossiers to domestic and international regulatory authorities to obtain marketing licenses. Interface with regulatory agencies to acquire marketing licenses (FDA approval orders, CE mark) for company products.
The VP of Quality and Performance Improvement is responsible for monitoring and evaluating the quality of care provided at Sky Ridge Medical Center, and for ensuring overall quality, risk management and infection control.
Manage all aspects of HEDIS improvement activities, including outreach, incentives, data integrity and chart review; review and implement new technological tools and processes and foster team concept with internal and external constituencies.
Responsible for the administrative and operational oversight of all hospital (enterprise) performance improvement, quality outcomes, risk reduction/mitigation, infection prevention, peer review, patient safety, and regulatory management operations.
Provide leadership for planning, management, implementation, integration and coordination of the Quality Department in support of facility goals dedicated to excellence, effective leadership, and financial stability.
Monitor the preparation and filling of regulatory reports in accordance with the policy and the risk assessment framework; operate independently of the day-to-day regulatory report preparation process.
Collaborates with IT and oversees the work of the HIM Manager, to assure the successful integration and implementation of compliant electronic medical record systems, transcription and medical coding processes.
Responsible for QA teams in a group of global sites. The QA teams are responsible for audit management, document control, CAPAs, complaints, adverse event reporting, final product release, and other QA related activities.