David Dills Email & Phone Number

Lakeland, Fl, Us

Mr. Dills is a Regulatory Affairs Consultant during the interim with more than 35 years in the life sciences domain within regulatory, regulatory intelligence, regulatory compliance, and QMS/QAE and evaluating new roles, opportunities and partnerships with companies. He was previously Director of Regulatory Services for CROMSOURCE (a ClinChoice Company) through May 30, 2024. Provides regulatory and compliance consultative services for early-stage, small and mid-size enterprises within medical devices, combination products, biotech and pharma products covering a spectrum of indications and product modalities, including SaMD and Digital Health. Supports Orphan Drug Designations for rare diseases for both FDA and EMA. Previously employed, with increasing responsibilities by medical device manufacturers/OEMs, and consultancies, including full-service CROs and has worked directly with manufacturers engaged in compliance remediation for enforcement actions. Strategic regulatory consulting applies to all phases from proof of concept, feasibility to pre-clinical/clinical FIH to product commercialization for marketing clearance and approval. Submission support includes 510(k), PMA, IDE, IND, BLA, NDA [505(b)(1) and 505(b)(2)] pathways, CTA, MAA, ODD for OOPD and EMA/COMP, and 513(g) and De Novo Requests. Designated US Agent/AR and works closely with the key stakeholders and Center Reviewers regarding Pre-Sub meetings, including Pre-IND (Type B, D, EOP2 meetings), Q-SUB, negotiations, and preparing briefing packets for FDA and EMA request for SA and Protocol Assistance. Collaborates with the stakeholders and provides regulatory submissions and postmarket project leadership/guidance. Manages regulatory/compliance projects with multiple competing priorities having a direct impact on site operations, regulatory approvals, and commercial opportunities while providing program strategy and operational clarity and ensures alignment on timeline, budget, scope, and deliverables.

Verona, Italy, It

Mr. Dills departed CROMSOURCE (a ClinChoice Company) as Director of Regulatory Services on May 30, 2024, as the position was eliminated due to redundancy. His scope of responsibilities included, but not limited to: • New strategies for additional business growth/services of the Regulatory Services Department• Business lead generation as requested by the Client Project Development Division/BD• Supported CPDDIV in the processing of requests for RFIs/RFPs/budgets • External regulatory training, conducted presentations/worked with KOL’s• Managed regulatory projects as PM/supported ClinOps clinical studies with multiple competing priorities having a direct impact on site operations• Liaison with functional areas; supported Regulatory Intelligence, Regulatory Database and Regulatory Library• Monitored the technical/commercial progress of projects ensuring compliance with deadlines/budgets• Developed Regulatory policies/procedures/templates• Managed the workload of the staff within RSD• Developed with the input of the Training & Qualification Management Unit, regulatory training materials-and performed training• Developed/reviewed RS SOPs/WIs to implement compliant regulatory processes; guide submission development and partner with Sponsors during submission development to the regulatory bodies, work with FDA/EMA and other Competent Authorities• Prepared the Regulatory Newsletter/White Papers/Case Studies for Corporate Marketing/Communications• Regulatory support for ClinOps, biometrics, medical monitoring; facilitated regulatory crisis management• Regulatory consultancy services for regional and/or global regulatory approvals/commercialization for investigational drugs/device products• Prepared/coordinated/managed regulatory submissions to Regulatory Authorities; established regulatory strategies/plans/conducted impact assessments• Pre-sub meetings with FDA/EMA, prepared briefing documents, negotiations, and post-filing support• US Agent

Mr. Dills joined CROMSOURCE in July 2018 for a new role after departing NovaQual. Responsibilities included but not limited to: • Facilitated and managed client relationships with biopharmaceutical/medical device clients• Directed and lead efforts to support business development and marketing strategy with multiple direct reports/management• Conducted regulatory and compliance related presentations at industry workshops/seminars • Directed and assisted with regulatory efforts for product development/NPI/commercialization strategy for medical devices, companion diagnostics, and bio/pharmaceuticals• Regulatory consultation for regulatory strategy including pre-IND/IND/IDE/PMA/510(k)/ANDA, DMF, and De Novo submissions • Consultation for IVDD/AIMDD/MDD Directives and CE-marking compliance• Consultation for post-marketing surveillance; MDR and Adverse Event/Incident Reporting, and GxP compliance; regulatory inspections• Directed and/or assisted with efforts involving enforcement actions, customer generated compliance events and remediation; and direct efforts for Compliance and oversight of GCP/GMP activities • Pre/post-market project leadership and guidance covering different therapeutic areas and medical specialties • Pre-Sub FDA and Sponsor meetings and address Agency requests for AI’s and remediating deficiency letters and RTA’s; establish supplier qualification programs for clients• Conducted MDSAP and UDI compliance consulting/regulatory training• Regulatory Liaison, US Agent and Official Correspondent • Readiness preparedness for FDA and Competent Authority inspections • Strategic regulatory consulting/planning for executing effective path to approval• Provide clinical trials/compliance support for clients with CRO/CMO• Conduct PAI, clinical, QS/GMP, and regulatory audits/assessments and remediation• Establish GxP programs, complete FDA registrations and device listing for clients

Mr. Dills, departed NovusLife in January 2016 as Senior Regulatory & Compliance Consultant and has an accomplished track record with 27 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established medical device, IVD and bio/pharmaceutical manufacturers on the global landscape. Prepared and submitted and/or remediated regulatory submissions.Previously employed, with increasing responsibilities by device OEMs and consultancies, including Parexel (CRO), Wipro and other consultancies, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA’s, warning letters, and customer generated compliance events, conducts GxP audits/assessments, serves as U.S. Agent/OC, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification.Defines strategies for approval to introduce new products to market, provides direction on GxP compliance, global submissions/dossiers, including product registrations/approvals for Asia Pacific, The Americas and EU, and involved in establishing QA systems with emphasis on preventing the design, manufacture, and shipment of defective products. Manages QS /regulatory issues related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution to achieve sustainable and proven compliant systems.Background encompasses broad capabilities in QMS development/remediation, postmarketing surveillance, compliance engineering, validation, SW V&V, CAPA, interfacing with FDA and the Regulatory Authorities, MDD/IVDD/CE Mark, ISO 14971/13485, and demonstrates credible experience to optimize business performance through proactive strategies to mitigate regulatory and compliance exposure.

Bachelor'S Degree, Environmental Science

Associate’S Degree, Biology/Biological Sciences, General

Education record

Associate Of Arts - Aa, Biology, General