Focused on providing comprehensive, strategic Quality and Regulatory consulting services for the Medical Device, Pharmaceutical, Biological Product, and Human Tissue Product industries. Innovative, Organized, and Customized compliance solutions, including:-Regulatory Remediation, including federal, international, state and local agencies (FDA Part 820, Part 1271, Part 11 and Part 210/211 compliance, EU MDR Updates, MDSAP, and ISO 13485).-Development, Improvement and Transition of Quality Management Systems.-Regulatory body registrations and submissions for market entry (Domestic and International, including 510(k), IND, BLA and IDE submissions). Regulatory body technical file updates, including EU MDR.-Auditing services, including both internal and external audits (GMP, GLP, GCP, GTP compliance and GAP assessments) and Audit Readiness (FDA, AATB, ISO 13485, MDSAP).-Guidance on product development efforts and associated regulatory pathway determination.-Assistance with Product Design Control, including PPAP, process validation development and execution, and Risk Assessment Plans/Mitigation (FMEA/pFMEA/dFMEA).-Project Management and Organizational Assistance.

Responsible for overall corporate quality assurance and regulatory compliance in support of human tissue products, orthopedic medical devices, and biological products. Focused on enabling innovation through principle-based compliance.-Management and training of QA, QC, QE and Document Control staff. Developed an organizational structure that was efficient and effective in supporting quality activities.-Directed Quality Assurance functions to ensure that all products manufactured met customer, company, quality and regulatory requirements.-Maintained regulatory documentation in support of CE marked medical devices, including technical file updates. -Streamlined processes by implementing risk-based validation methodology to improve risk mitigation and increase quality and efficiency.-Executed on-site audits of suppliers to ensure compliance to FDA regulations and AATB standards.-Managed all levels of audits/inspections: regulatory (FDA/AATB/Notified Body), client, internal and external. Responded to audit reports and implemented corrective plans of action.-Maintained Quality databases and used data to prepare trending reports for communication to executive management.-Lead recruitment strategy to attract and retain high-quality performers.-Assessed computer applications for FDA regulatory (Part 11) and internal validation requirements. -Coordinated validation testing and data collection to support product development projects.-Authored submissions for product approval by domestic and international regulatory bodies (FDA 510(k) and BLA, TGA, KFDA, and COFEPRIS).-Performed complaint handling for all applicable customer feedback, including documentation, investigation, and FDA reporting determination (HCT/P and MDR). -Responsible for all aspects of Quality Assurance, including CAPA/NCR, Change Control, Training, and Continuous Improvement.

Provided active instruction to nursing students, including both lecture and laboratory instruction in the areas of Biology and Anatomy and Physiology. Developed course curriculum. Participated in the advising, mentoring, and tutoring of students within the nursing program. Attended faculty meetings. Assisted senior professors with lecture and laboratory preparation.