Ellie Reynolds is the Director of Regulatory Affairs and Quality Assurance at Proxima Clinical Research, a contract research organization that serves the emerging drug and medical device industries. At Proxima, Ellie has been critical in contributing to and authoring regulatory strategies and assessments, pre-submission, pre-IND, IND, and IDE packets, and 510(k), De Novo, and PMA submissions for products across a range of indications, including cardiovascular, gastrointestinal, urology, surgical, diagnostic, and pediatric-specific devices. She has also been instrumental in QMS development and integration projects for both large and small companies.  

Prior to joining Proxima, Ellie completed her Master of Engineering in Bioengineering with a focus in global medical innovation at Rice University, where she worked on multiple medical devices from need identification through the entire development process.  She also worked as a consultant at a small life science consulting firm where she performed market landscape assessments and provided strategic insights to major pharmaceutical companies. She has also served in additional regulatory affairs and quality assurance roles in which she developed regulatory and technical transfer strategies for both medical device and pharmaceutical companies across a range of therapeutic indications.

Ellie graduated summa cum laude from Vanderbilt University with a Bachelor of Engineering in Biomedical Engineering. Throughout her undergraduate career, she engaged in a variety of research projects, from developing patient wearables to improve ICU recovery to characterization of protein presence in heart valve cells through fluorescence-activated cell sorting techniques.

Vanderbilt University: Biomedical Engineering, B.S.

Rice University: Bioengineering, M.B.E

Proxima Clinical Research, Inc., Houston, Texas
Director of Regulatory Affairs and Quality Assurance
Associate Director of Regulatory Affairs and Quality Assurance

Johnson & Johnson Center for Device Innovation, Houston, Texas
Innovation Fellow

Putnam Associates, Boston, Massachusetts
Associate Consultant

Regeneron Pharmaceuticals, Rensselaer, New York
Technical Transfer Intern

Texas Scottish Rite Hospital for Children, Dallas, Texas
Biomechanics Intern

Vanderbilt University, Nashville, Tennessee
Research Assistant

Ms. Reynolds has played an important role in the development of the following medical products:

Drugs: COVID-19 (x2), Acute Respiratory Distress Syndrome (ARDS), Atopic Dermatitis, Hypercholesterolemia, Solid Tumors (x2), Nuclear Radiation Exposure, Genital Warts

Cardiovascular & Circulatory Devices: Mechanical Circulatory Support Device (x3), Cardiac Assist Device, Non-Invasive Blood Pressure Monitor (x3), Non-Invasive Atrial Fibrillation Screening Device, Acoustic Cardiography Device, Balloon Catheter, Vascular Access Catheter, Arteriovenous Fistula and Graft Support Device

Neurological & Neuromodulation Devices: Neuromodulation (x3), Brain-Computer Interface, Phrenic Nerve Stimulator, Stroke Detection Device (x2)

Pediatric Devices: Pediatric Stent (x2), Pediatric Intraurethral Valve Pump and Activator (x2), Infant Feeding Measurement Device, Neonatal Incubator

Diagnostic & Monitoring Devices: IVD for COVID-19 Detection, IVD for Group B Streptococcus Detection, App for Vision Testing and Monitoring, App for Remote Monitoring of Patient Visual Health, Ultrasound Otoscope, Handheld Ultrasound Device for Solid Tumor Detection, Software for Osteoarthritis Detection, Automated Image Segmentation Software, Tracheal Tube Monitor, Esophageal Temperature Monitoring Probe, Physical Therapy Tracking Device

Respiratory & Critical Care Devices: Mechanical Ventilation Device (x2), Pleural Effusion Treatment Device, Intubation Tube Placement Device, Incubator Noise Reduction Device, Intermittent Negative Pressure Therapy Device

Surgical & Interventional Devices: Direct Therapeutic Ultrasound Surgical Tool, Ablation Needle, Microwave Ablation Catheter, Disposable Laparoscope, Catheter Torque Device, Anastomotic Coupling Device and Laparoscopic Tool, Laparoscopic Specimen Segmentation and Removal Tool, Gastroscope, Biliary Catheter and Pump, Organ Perfusion Device, Pressure Infusor, Laboratory Robot

Urological & Renal Devices: Intraurethral Valve Pump and Actuator (x2), Wearable Percutaneous Tibial Nerve Stimulation for Overactive Bladder, Peritoneal Dialysis Catheter, Intraperitoneal Insulin Delivery Device

Wound Care & Tissue Products: Regenerative Dermal Filler, Sprayable Hydrogel, Hydrogel Adhesive for Wound Healing, Wound Dressing (x2), Serum-Infused Tampon

Other Therapeutic Devices: Software for Autism Treatment, Contraceptive Tubal Occlusion Implant, Intragastric Implant for Morbid Obesity, Autoinjector

Poster presentation at International Conference for Auditory Displays (ICAD)