Jamie Blose is a legal, multi-faceted professional with 25+ years of experience combining specialized expertise in drug and medical device development and law. She is a versatile professional that utilizes legal and operational expertise to quickly analyze and mitigate issues facing research and development organizations and find practical solutions. Jamie consistently builds high-performing and collaborative teams. A highly detailed, thorough, efficient professional noted for high stakes, and complex issue resolution. Jamie has significant expertise in complex corporate transactions, SEC disclosures, corporate governance, compliance, board management, and employment matters. She has built and led legal departments, oversaw outside counsel, managed corporate partnerships, and supported diagnostic, device, preclinical, clinical, and commercial development organizations. Jamie has provided leadership and training for legal policies, compliance, ethics, HIPAA, PhRMA, FMV, GDPR, GxP and QMS issues, brought companies into compliance, prepared companies/sites/vendors for regulatory inspections, and led both drug and medical device sponsor inspections. She has managed various departments and teams in support of product development and commercialization across various therapeutic areas and all phases of development. Jamie is experienced in INDs, NDA’s including 505(b)(1) and 505(b)(2), PMAs, 510(k)’s and launch activities.