Meet Our Experts

Ellie Reynolds, MBE

Associate Director of Regulatory Affairs and Quality Assurance
About
Education
Positions & Honors
Contributions to Science
Additional Information
Originally From:
Dallas, TX
Fun Fact:
Ellie loves distance running and is planning to run the Chicago marathon this fall.
About

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.

Education

Vanderbilt University: Biomedical Engineering, B.S.

Rice University: Bioengineering, M.B.E

Positions & Honors

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

Contributions to Science

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  
Additional Information

Poster presentation at International Conference for Auditory Displays (ICAD)