Services/Experience

As a solutions oriented leader, Robert has consistently achieved positive results in all industry aspects for regulatory and operational processes and systems.

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He specializes in:

-Worldwide corporate regulatory compliance programs
-Business Venture Start-up and Mergers/Acquisitions
-Providing expert analysis of FDA and international regulations
-Public policy and testimony for healthcare issues before federal and state agencies
-More than 100 FDA PMA approvals and 510(K) clearances of medical devices (CDRH & CBER)
-Robust, compliant Clinical Studies
-CLIA Waiver and Point-of-Care (POC) Diagnostics
-Design control process development implementation
-Industry Liaison to Clinical Laboratory Improvement Advisory Committee (CLIAC)
-Software validation for FDA submissions
-International Product Registrations (e.g. EU IVD Directive, Asia, Canada, Latin America)
-FDA Unique Device Identifier (UDI) Compliance
-HIPAA Compliance Training
-Corporate code of ethics establishment and implementation
-Establishment and implementation of Corrective and Preventive Action (CAPA) systems
-Master Process validation plans
-Foreign Corrupt Practices Act (FCPA) Mediation
-Managing the post market product surveillance lifecycle process
-Document Control Systems
-New product technology transfer to manufacturing and pilot plant operation