Marcella Garcia
Details
2018 : Present
Compliance Center - Medical Device Compliance
Fractional Consulting - Regulatory Affairs, Quality Assurance, Information/Cybersecurity - SaMD
Nia Therapeutics is developing precision brain stimulation therapies to treat memory loss due to brain injury and degenerative disease. Nia’s technology was developed at the University of Pennsylvania with funding from DARPA.
2022 : 2023
Nia Therapeutics
Vice President Regulatory Affairs and Quality Assurance - Neurostimulation / Active Implantables
Transformed the Information Security program in six months to achieve HITRUST certification. Building an AL/ML focused QMS from the ground up in 2022 with a focus on authoring core business processes, driving best practices around design controls and V&V. Creating regulatory strategies and advising on regulatory pathways that align with the product roadmap and company vision.
2021 : 2022
Health Data Analytics Institute
Sr. Director of Quality and Compliance (CISO) - Predictive Analytics Population Health
Reporting to C-Suite, lead the cross functional product team in design controls, V&V, and regulatory pathway guidance during COVID. Worked with IT to achieve HITRUST certification. Provided leadership to the Clinical team for CRO selection and procedures compliant to ISO 14155.
2019 : 2021
Happify Health
Director Of Quality and Compliance - Digital Therapeutics
Working with partners worldwide to develop innovative technology in the fields of particle therapy, industrial control, scientific research.
Reporting to the C-Suite, built the Regulatory and Quality organization from the ground up. Collaborated with one of the world’s leading providers of proton therapy systems on multiple international installations. Worked closely with other proton therapy providers to ensure FDA submissions and risk management activities. Lead all audit activities both internal and supplier facing.
2012 : 2018
Pyramid Technical Consultants, Inc.
Sr. Director - Regulatory, Quality & Risk Management - Proton Therapy for Cancer Treatment
About
Medical Device | SaMD | FDA - Quality - Regulatory - Clinical - Compliance - Risk Management - Design Controls - Cybersecurity - HIPAA - HITRUST - SOC2: HCISPP Certified - Available for fractional C level / executive level advisory and consultancy in Regulatory Affairs, Quality Assurance, Information Security, Compliance, and Operations.
Regulatory / Quality / Clinical 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 (presubs, 510k, IDE, PMA, etc) - 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, FDA, GMP, GCP, and more.
Creative-strategic thinker with a focus on accelerating execution and delivery, organizational innovation, customer satisfaction, and continuous improvement.
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