Ellie Reynolds is the Associate 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
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:

1. Drug for COVID-19 (x2)
2. Drug for Acute Respiratory Distress Syndrome (ARDS)
3. Drug for Atopic Dermatitis  
4. Drug for Hypercholesterolemia
5. Drug for Solid Tumors (x2)
6. Drug for Nuclear Radiation Exposure
7. Drug for Genital Warts
8. Medical Device – Mechanical Circulatory Support Device (x3)
9. Medical Device – Cardiac Assist Device
10. Medical Device – Mechanical Ventilation Device (x2)
11. Medical Device – IVD for COVID-19 Detection
12. Medical Device – IVD for Group B Streptococcus Detection
13. Medical Device – Neuromodulation (x3)
14. Medical Device – Brain-Computer Interface  
15. Medical Device – Phrenic Nerve Stimulator
16. Medical Device – Balloon Catheter
17. Medical Device – Non-Invasive Blood Pressure Monitor (x3)
18. Medical Device – Non-Invasive Atrial Fibrillation Screening Device
19. Medical Device – Acoustic Cardiography Device  
20. Medical Device – Pediatric Stent (x2)
21. Medical Device – Pediatric Intraurethral Valve Pump and Activator (x2)  
22. Medical Device – Biliary Catheter and Pump
23. Medical Device – Organ Perfusion Device
24. Medical Device – Gastroscope
25. Medical Device – Software for Autism Treatment
26. Medical Device – Intraurethral Valve Pump and Actuator (x2)
27. Medical Device – Infant Feeding Measurement Device
28. Medical Device – Laboratory Robot
29. Medical Device – Neonatal Incubator
30. Medical Device – Incubator Noise Reduction Device
31. Medical Device – Direct Therapeutic Ultrasound Surgical Tool  
32. Medical Device – Stroke Detection Device (x2)
33. Medical Device – Pleural Effusion Treatment Device
34. Medical Device – Software for Osteoarthritis Detection  
35. Medical Device – Vascular Access Catheter
36. Medical Device – Arteriovenous Fistula and Graft Support Device
37. Medical Device – Intubation Tube Placement Device
38. Medical Device – Contraceptive Tubal Occlusion Implant
39. Medical Device – Peritoneal Dialysis Catheter
40. Medical Device – Ablation Needle
41. Medical Device – Intragastric Implant for Morbid Obesity
42. Medical Device – Microwave Ablation Catheter  
43. Medical Device – App for Vision Testing and Monitoring
44. Medical Device – Disposable Laparoscope
45. Medical Device – Ultrasound Otoscope
46. Medical Device – Catheter Torque Device
47. Medical Device – Intraperitoneal Insulin Delivery Device
48. Medical Device – Serum-Infused Tampon
49. Medical Device – Handheld Ultrasound Device for Solid Tumor Detection
50. Medical Device – Regenerative Dermal Filler
51. Medical Device – Sprayable Hydrogel
52. Medical Device – Physical Therapy Tracking Device
53. Medical Device – Anastomotic Coupling Device and Laparoscopic Tool
54. Medical Device – Tracheal Tube Monitor  
55. Medical Device – Intermittent Negative Pressure Therapy Device
56. Medical Device – Pressure Infusor
57. Medical Device – Wearable Percutaneous Tibial Nerve Stimulation for Overactive Bladder
58. Medical Device – Esophageal Temperature Monitoring Probe
59. Medical Device – App for Remote Monitoring of Patient Visual Health  
60. Medical Device – Laparoscopic Specimen Segmentation and Removal Tool
61. Medical Device – Hydrogel Adhesive for Wound Healing
62. Medical Device – Wound Dressing (x2)
63. Medical Device – Automated Image Segmentation Software
64. Medical Device – Autoinjector  

Poster presentation at International Conference for Auditory Displays (ICAD)