David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, addressing enforcement actions and mitigating compliance exposure for companies via remediation, compliance engineering support, post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing; and working with Notified Bodies, and AR's. David manages regulatory problems (e.g. AE's, MDRs, Agency enforcement, complaints/investigations, field alerts/recalls) 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. This is based on analyzing the benefits/risks for informed decision-making and interprets the regulatory precedents and new legislation. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones. David has been previously affiliated with well-known device manufacturers and service providers, including a global CRO and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background and areas of interest and focus.
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