James Wabby

WORK HISTORY

EDUCATION

ABOUT JAMES WABBY

Regulatory Affairs, Clinical/Product Development, Quality Management, and Operations Experience (Emerging Technologies, Combination Products, and Medical Devices) • Assist product development project teams, clinical affairs, supply chain, and manufacturing production teams in the quality and regulatory areas of Emerging Technologies, Device and Combination Products development from early stage clinical through commercialization • Establishment of quality management systems (mfg, clinical, laboratory) • Global Regulatory and Quality Operations Management • Quality Reports/Metrics to senior management at Management Review and/or Council Meetings. • Regulatory Affairs,CE Marking Requirements, Regulatory Strategy for Submissions • Support combination product regulatory submissions, including collecting feedback and HA meetings, IND, NDA (505-b2, 505-b1), ANDA, BLA, IDE, PMA, 510(K), De Novo, 513-g, CTA and MAA. • Regulatory Intelligence • Establishment Registrations/Listings • Management of Field Actions and Pre-Market Product Recoveries - ISO 13485, MDSAP, MDR/IVDR and global (GxP) requirements - Process-based Internal Auditing and Supplier Audits - CAPA and Deviation Management tracking systems - Materiovigilance, PV, Risk Management, Design Control and Human Factors Engineering Lead Global Biomedical Quality and Regulatory Audits • Lead Auditor Certified with Medical Device Focus (QSR/GMP/ISO 13485/9001) and GCP/GLP audits • Merger/Acquisition/Business Development Assessments - Inspection Readiness. • Representing the company during Global Ministries of Health, CDC, State, Certification and Notified Body Inspections. Compliance Oversight:* PhRMA Code, PDMA, Corporate Integrity Agreements, AdvaMed, Medicare/Medicaid, Coding ICD and CPT, Anti-Kick Back, False Claims Act, Stark, HIPAA, EU Data Privacy.* Facilitating FDA 483, Warning letter and CAPA responses to Regulatory Authorities.