Independent Regulatory & Compliance Consultant, with an accomplished record has more than 22 years of hands-on experience with emphasis on Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of QA, Regulatory Affairs and Compliance. Since 2000, has provided consultative services on behalf of global manufacturers and subcontracted by third-party consultancies and provides services involving all key stages of the product development, submission, and commercialization process, inspection readiness preparation, GxP compliance, execute audits and regulatory assessments, execute remediation and regulatory strategies, postmarketing surveillance/vigilance reporting, clinical affairs, deploy and remediate QMS and documentation systems, preparation for ISO 13485 registration and CE Mark, and multi-country device registrations. He has been previously employed, with increasing responsibilities by medical device firms and consultancies, including a globally recognized CRO.

Mr. Dills manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations/commercial opportunities. Develops strategies for governmental approval to introduce new products to market, provides “hands-on” guidance on regulatory requirements, and constructs and reviews drug and device submissions [e.g., 510(k), PMA, IDE), and dossiers/technical files, including applications/registrations for the Pacific Rim, The Americas and EU, and involved in establishing and deploying QA systems with emphasis on preventing the design, manufacture, and shipment of defective products. Manages QS and regulatory problems (e.g. adverse events, MDRs, Agency enforcement and complaints) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems and regulatory affairs, validation, and interfaces with FDA and other governmental agencies on the global landscape, MDD/IVDD Directives, ICH, ISO 14971 and 13485, and IEC 60601 and other testing standards and demonstrates credible experience to maximize performance and optimizes business performance through proactive strategies to mitigate compliance exposure. Develops strategies and adds business value to manufacturers by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones and on minimizing delays due to noncompliance.

Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute and currently serves on the Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of Professionals. Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills’ academic degrees include Environmental Science and Biology. He is a former Chair and Co-Chair of ASQ’s Section 1506 and an active member of the Biomedical Division, RAPS, PDA, ISPE, and other industry working groups.