Rachelle Y.
Director of Clinical Operations and Medical Affairs @Return To Duty
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WORK HISTORY
Director of Clinical Operations and Medical Affairs @Return To Duty
Partner to establish a network of orthopedic and neurologically trained spine surgeons and act as a liaison of scientific and clinical communication in support of military special operation force (SOF) advocacy, treatment, and clinical education for back pain and spine injuries. Establish HIPPA-compliant patient provider portal/remote clinical triage of active and retired SOF community members, resulting in successful virtual round table case reviews performed by a network of ortho/neuro spine surgeons, allowing SOF operators unbiased care recommendations focused on anatomy conservation and motion preservation techniques for treatment of spinal pathologies. Organize virtual and in-person clinical education and community outreach events related to back pain, spinal pathologies, new technology, and treatment options, driving program adoption and partnerships within the U.S. military branches.
EDUCATION
Johns Hopkins Whiting School of Engineering
Master of Science - MS, Biomedical Engineering
Florida Gulf Coast University
Bachelor of Engineering - BE, Biomedical Engineering
Florida SouthWestern State College
Associate of Arts (A.A.), Chemistry
ABOUT RACHELLE Y.
Medical device leader experienced in establishing scalable Quality Management Systems compliant with ISO 13485, ISO 14971, ISO 9001, FDA 21 CFR 820, 21 CFR 803, 21 CFR 806, EU MDD 93/42/EEC, and EU MDR 2017/745, as well as combination devices compliant with 21 CFR 210/211, to drive company operational efficiencies and increase the rate of new product commercialization. Certified Biomedical Auditor, experienced in leading FDA and Notified Body assessments, as well as supplier qualification and surveillance audits of Class I, Class II, and Class devices, including implantable, reusable, and combination products subject to various manufacturing environments, process handling requirements, and sterility conditions. Accomplished in product and process development, utilizing quality, regulatory, and biomedical engineering principles to test and optimize Class I, II, and medical devices under domestic and international requirements. Experienced in leading multi-center clinical investigations of medical devices in human subjects (GCP) in accordance with ISO 14155:2020 and other applicable regulations and standards for new and existing products to demonstrate product safety and support distribution in expanded international territories.
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