Seasoned medical device executive (VP Regulatory, VP Quality, VP Clinical) with 30 years of increasing responsibility in regulatory, quality, and clinical affairs. Solution oriented individual with solid understanding of US and international regulatory requirements allowing development of highly effective and efficient regulatory strategies that deliver the fastest time to market for new and modified medical device technologies. Builds strong relationships with internal cross-functional customers and external regulatory agencies. Extensive knowledge of quality system regulations (21 CFR 820) and standards (e.g., ISO 13485). Key experience includes:- Development of early feasibility and pivotal clinical trial strategies- Product development cross-functional team member- Key negotiator with FDA and other regulatory bodies- Provided regulatory review of advertising and promotional materials- Device change assessments for regulatory impact- Managed Medical Device Reporting (MDR) activities- Experience hosting FDA and international inspections/audits- Prepared responses to inspectional/audit findings (483s, Warning Letters)- Planned and implemented worldwide product recall activities- Prepared for and presented at FDA Advisory PanelsSpecialties: PMA, PMA Supplements, 510(k), IDE, Pre-Submissions (formerly Pre-IDE), CE Mark, Regulatory Strategy, Clinical Strategy, Design Controls, Due Diligence, Quality Systems, Complaints, CAPA, Regulatory Compliance, Cardiovascular Devices, Neurological Devices, Ophthalmic Devices, Trade Associations