Medical Device | SaMD | FDA - Quality - Regulatory - Clinical - Compliance - Risk Management - Design Controls - Cybersecurity - HIPAA - HITRUST - SOC2: HCISPP Certified, LQMS - Available for fractional C level / executive level advisory and consultancy in Regulatory Affairs, Quality Assurance, Information Security, Compliance, and Operations.Regulatory & Quality Compliance specialist with ten years working at the executive level in Class II/III complex electro-mechanical medical devices, SaMD, digital therapeutics, AI/ML, IVD, control systems, and electronic diagnostic hardware and over fifteen years working with complex technologies, integration, supplier management, and operational excellence. Technical expertise in building design history files and regulatory submissions - leading audits and certification activities. Strong regulatory background with direct experience designing and managing compliance to standards such as HIPAA, HITRUST, SOC, ISO 13485, ISO 14971, ISO 14155, ISO 27001, IEC 62304, IEC 60601, ISO 15189, FDA, GMP, GCP, and more. Looking forward to sharing expertise in "right sizing" QMS best practices for labs. The FDA's update to LDT's will bring more labs to the table to build new or evolve their existing quality systems.Creative-strategic thinker with a focus on accelerating execution and delivery, organizational innovation, customer satisfaction, and continuous improvement.