David R. Dills, Global Regulatory Affairs & Compliance Consultant, Interim President, currently provides global regulatory affairs, compliance, and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, nutraceuticals, and biotech/biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas, including orphan drugs on the global landscape, and has an accomplished record with more than 28 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO, and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA’s, warning letters, 483 observations, and customer-generated compliance events, and prepares for and conducts QS, supplier, and regulatory audits. He provides oversight of GCP operations and clinical trials and prepares companies for regulatory inspections at all phases. He has been directly involved with constructing, reviewing, and/ or remediating regulatory submissions and applications, including 510(k), PMA, IDE, HUD, pre-IND/IND, BLA, CMC,/eCTD, e-TMF, ANDA, and NDA submissions, preparing responses to AI’s and deficiency letters, Supplements, Amendments, acting U.S. Agent, works closely with the key stakeholders and Agency/Center Reviewers regarding Pre-Sub meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and postmarket project leadership and guidance covering different therapeutic and medical specialties based on classification. He has hands-on experience with all phases of medical device premarketing and postmarketing commercialization and for drug development and biopharma manufacturing operations. Mr. Dills has a strong background in the interpretation and applicability of FDA regulations for medical device, biologics, and pharmaceuticals, conducts customized GxP training, leads and directs activities for the registration and approval process, and working with Agencies in the Asia Pacific, EU, and The Americas, including but not limited to FDA, European Medicines Agency– EMA, MHRH, ANVISA, PMDA, MOH, SFDA, ANVISA, TGA, and Health Canada; defining and executing regulatory compliance, risk mitigation and remediation strategies in response to inspection findings. Additional activities include Pre-FDA Facility Inspections, Mock Audits/Due diligence and assessing the state of readiness for Pre-approval inspection (PAI/PMA), proof of management oversight, facilitate and direct efforts for remediation planning and monitoring, and assessment of the critical sub-systems, records and document controls; and strives for a reduction of regulatory compliance risk for companies. He has been involved in all phases of Class I/II recall.