Christopher Morgan Email & Phone Number

San Diego, California, United States

-Delivered biocompatibility evaluation plans/reports, and toxicological risk assessments complying with applicable biological evaluation standards and FDA/ISO guidance documents within a risk-based framework-Collaborated with a cross-functional team to support multiple projects requiring biocompatibility evaluation ensuring the timely completion of tasks necessary to meet project schedules-Performed and assisted gap analysis of external standards, regulatory requirements, and guidance associated with biological safety evaluation, and minimized the negative impact of such gaps on ResMed products and business-Assisted with regulatory submissions to global regulatory agencies in order to elaborate on the ResMed product biocompatibility strategy and data in response to additional information requests-Analyzed biocompatibility test results to determine the adequacy of data to meet requirements for the biological effects, and utilized problem-solving skills and technical knowledge to troubleshoot unexpected results

Washington Dc-Baltimore Area

-Led interdisciplinary team of engineers and business professionals through R&D, fundraising, 510(k) FDA approval process, and internal device testing (biocompatibility and stress tests) for novel biomedical device(s) -Performed Risk Management per ISO 10993-1:2018, ISO 13485:2016, ISO 14708-1:2014, ISO 18562-1:2017 for pneumatically driven ventilator, class II medical device, to achieve FDA approval -Authored proposal documentation for 510k, NSF, SBIR, and DOD grants

Bethesda, Maryland, United States

-Led an interdisciplinary team of engineers and business professionals through R&D, fundraising, and approval process for novel biomedical device -510(k) document preparation and submission-Developed fully realized business plan and white paper -Designed and maintained Microsoft Project timelines to ensure project deliverables and milestones met-Analysis of global and regional market research to target key markets, customers, producers, and growth potential -Oversaw multi-platform social media outreach

United States

-Managed supply chain of common and rare indications throughout the importation, validation, and sales process-Progressed and improve patient data importation and analysis from an expansive network of global hospitals -Expedited and provided the administrative groundwork for 5 project managers and $12,000,000 annual projects

Columbus, Ohio Area

-Designed a novel polymer-ceramic composite for enhanced periosteal tissue expansion-Devised a protocol for the decellularization of periosteal tissue for use in bone wound repair where growth factors retained in tissue were found to enhance new bone ingrowth -Examined the regenerative capacity of periosteal tissue for the healing of non-unions and tissue mineralization-Analyzed the mineralization rate and new bone ingrowth of implanted 3D printed polymer scaffolds, in a mouse model, through µ-CT imaging and histomorphometric analysis

Master Of Science - Ms, Materials Science And Engineering, 3.5

Bachelor'S Degree, Materials Science