Nineteen years of direct hands-on experience in Class I/II/III medical devices and In-Vitro diagnostics.   Extensive experience in Pharmaceutical and Biologic operations in the areas of regulatory affairs, compliance, validation and quality systems to ensure compliance with FDA and international regulations.

Titles Held: Director of FDA Regulations and Compliance; Corporate Director of Technical and Regulatory Compliance; Corporate Manager of QA/RA; Manager of Quality Engineering

• Expertise in executing process validation, remediation, supplier qualification, training, internal/due diligence audits and policy/procedure development
• Skilled in Risk Management/Assessment; ISO 9001/13485/14971; MDR/AE/product complaints and CAPA’s
• International experience in Japan, EU and Canada regulatory bodies/agencies; also MDD 93/42/EEC and CE Mark and Notified Bodies
• Experience with PMA’s, IDE’s, 510(k)’s, NDA’s and e-CTD/CMCs submissions
• Knowledge with inspection readiness for manufacturers

ASQ professional with twenty-two years of experience in regulatory compliance, project management and business process improvement. Industry experience in drugs, biologics, medical devices, IVDs, and tissue banking.

Titles Held: Director of QA/RA; Principal; Corporate Director of Quality /Regulatory; QA/RA Specialist; Project Coordinator, Manager of Clinical Services

• Proven capability to accomplish results in different countries and varied business functions
• Strong FDA applications for Biologics IND Phase O to III; FDA applications for medical devices and IVDs, IDE’s through PMA’s
• Experience with Quality programs, Design Control, SOPs, Assessments, Validation and CAPA’s
• US, EU, and CE Marking medical devices and diagnostics; EU and ISO quality management audits
• Experienced Auditor with QSR, EU, GC; prepared and received accreditation in EU GMP, QSR, ISO 13485, ISO 9001

Seasoned professional with thirteen of years experience in both Domestic and International Regulatory Affairs and Quality Systems. Strong 510(K) submission work and extensive knowledge of implementation of total quality system certifications for the Medical Device industry.

Titles Held: Manager of Quality Assurance and Regulatory Affairs; Senior Quality Engineer; RA Specialist

• Expert in Process and Software Validation; Knowledgable QSR Trainer
• Extensive experience with FDA Inspections and Quality system Audits
• Experience with Class II Intravascular Devices; clinical trials
• Experience working RA and QA systems in the US, EU, Asia Pacific and Latin America; CE Marking experience
• Certifications: RAC, ASQ, CQA, RAB-Certified Lead Quality Auditor

RAC/CQA professional with over twenty-five years experience with Medical Device Regulation in Compliance Management, Regulatory Affairs, Quality Systems and Clinical Affairs. Specializes in creative regulatory strategies to expedite product registrations.

Director of Regulatory Affairs; Corporate Director, RA/QA; Manager of Regulatory Affairs; RA/Clinical Associate

• Develop Design Control Systems and Implementation; experienced in working with product development teams to get medical devices to market in a timely manner
• Strong experience with Regulatory Compliance Programs, GMP/QSIT Audits, and Gap Analysis
• Develop and implement ISO 13485 compliant Quality Systems
• Possess extensive knowledge and expertise of FDA device regulations, EU Medical Device Directive (MDD), Notified Body Audits, FDA QSIT inspections, and IRB/IDE submissions
• International Submissions: Design Dossier and Technical File Development; Lead CE mark projects
• Extensive experience with compliance issues, Warning Letters, product recalls, facility inspections and resulting 483 responses and consent decrees