David R. Dills, Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape.
Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA’s, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA, Design Dossiers, Technical Files, CMC, NDA, and IDE submissions, currently serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. His background encompasses broad capabilities in regulatory and compliance oversight and governance, including CAPA, Design Controls, Validation, Software Quality with regulatory oversight, FDA Mock Inspections, remediating documentation management systems, Supplier Quality, Adverse Event Reporting, Product Complaints, GxP Training, interpretation and applicability of FDA and international regulations and standards, postmarketing surveillance, ISO 13485 and CE Mark, Medical Device/IVD/Active Implantable Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EMEA and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.