15 years of progressive experience in regulated healthcare or consumer-product quality, post-market surveillance, food safety, tissue compliance, or regulatory operations, including substantial experience leading globally distributed leaders and teams responsible for recalls, corrections, removals, market withdrawals, regulatory authority communications, inspections, or notified body audits. Advanced knowledge of FDA and global Field Corrective Action requirements applicable to medical devices, pharmaceutical products, cosmetics, food products, and human cells, tissues, and cellular and tissue-based products, including relevant quality, risk management, adverse event, traceability, recall, correction, removal, market withdrawal, and regulatory communication requirements.