Isabella Schmitt, MBA, RAC

University of New Orleans: Chemistry, B.S.

Regulatory Affairs Professional Society: Devices, R.A.C.

Texas A&M: Business, M.B.A.

Isabella currently serves as the Director of Regulatory Affairs at Proxima Clinical Research, a contract research organization that serves the emerging drug and medical device industries. 

Prior to joining the Proxima team, Isabella served as the Senior Regulatory and Quality Manager for a medical device company where she was charged with outlining the regulatory strategy and putting together design controls and design history documentation, and as the Director of CMC and Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.  

Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications. Isabella is a judge and mentor for MedTech Innovator, and in her spare time, she serves as a TMCx advisor and speaker, helping companies with regulatory affairs, quality, and clinical development questions, and as a MassChallenge Houston judge and mentor.  She also serves as a pitch coach for SXSW Pitch Competition.

Proxima Clinical Research, Houston, Texas
Director of Regulatory Affairs
Regulatory Affairs Consultant‍

ColubrisMX, XCath, Houston, Texas
Senior Regulatory and QA Manager

Repros Therapeutics., The Woodlands, Texas
Director of CMC and Quality‍

Repros Therapeutics, The Woodlands, Texas
Regulatory Affairs Associate‍

Repros Therapeutics, The Woodlands, Texas
Clinical Research Associate ‍

University of New Orleans, New Orleans, Louisiana
‍Research Assistant

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

1. Drug for Male Testosterone
2. Drug for Endometriosis
3. Drug for Uterine Fibroids
4. Drug for Vaginal Atrophy
5. Drug for Colon Cancer
6. Drug for COVID-19
7. Drug- Oncolytic Virus
8. Nutritional Supplement for Cystic Fibrosis (pediatric)
9. Medical Device for Group B Streptococcus (pediatric)
10. Medical Device for Asthma Monitoring (pediatric)
11. Medical Device- IVD for Sepsis Detection
12. Medical Device- Software for Sepsis Detection
13. Medical Device for Gas Collection
14. Medical Device for Urine Flow Measurement (pediatric)
15. Medical Device for Spinal Fusion
16. Medical Device for Neuromodulation (x4)
17. Medical Device- Software for Wound Management
18. Medical Device- Surgical Robot
19. Medical Device- Vascularization imaging surgical device
20. Medical Device- Catheter Guidewire
21. Medical Device- Balloon Catheter
22. Medical Device- Heart Valve (pediatric)
23. Medical Device- Left Ventricular Assist Device (LVAD) or MCS (x4)
24. Medical Device- Non-Invasive Blood Pressure Monitor (x3) (one pediatric)
25. Medical Device- Software for Atrial Fibrillation Detection
26. Medical Device- Biliary Catheter and Pump
27. Medical Device- Software for Flow Cytometry Data Analysis
28. Medical Device- Detection of Cerebral Blood Flow for Stroke Rehabilitation
29. Medical Device- IVD for Melanoma Risk Assessment
30. Medical Device- Anchors for Fetoscopic Surgeries (pediatric)
31. Medical Device- Gastric Sleeve and Anchor
32. Medical Device- Breast Localization Wire
33. Medical Device- Gallbladder Cryoablation
34. Medical Device- Noise attenuation for neonates (pediatric)
35. Medical Device- Surgical margin detection device (x2)
36. Medical Device- Organ Perfusion Device
37. Medical Device- Perfusion Catheter
38. Medical Device- Surgical Adhesion Material
39. Medical Device- IVD for bacterial detection  
40. Medical Device- Sleep apnea relief
41. Medical Device- Vascular patch
42. Medical Device- Software for radiology  
43. Medical Device- Heart Rhythm management device
44. Medical Device- Laboratory Robots
45. Medical Device- Gastroscope (pediatric)
46. Medical Device- Software for cancer management
47. Medical Device- Software for autism treatment (pediatric)
48. Medical Device- Intra-urethral valve pump and activator (x2) (pediatric)
49. Medical Device- IVD for Barret’s Esophagus  
50. Medical Device- IVD for necrotizing enterocolitis (pediatric)
51. Medical Device- Camera for ophthalmology
52. Medical Device- Infusion pump
53. Medical Device- Software for depressive disorder
54. Medical Device- Stroke Cooling Device  
55. Medical Device- Ventilator
56. Medical Device- IVD for COVID-19
57. Medical Device- Infant feeding measurement device (pediatric)
58. Medical Device- Software for attentional deficit disorders (pediatric)
59. Medical Device- Diagnostic for ear infection (pediatric)
60. Medical Device- Neonatal Incubator (pediatric)
61. Medical Device- Scoliosis (pediatric)
62. Medical Device- Intubation system
63. Medical Device- Ultrasound surgical system  
64. Medical Device- Nasal spray delivery
65. Medical Device- Coronary stent
66. Medical Device- Epilepsy (pediatric)
67. Medical Device- Diabetes test (pediatric)

Contributed to Regulatory Focus

American Chemical Society Undergraduate of the Year

Poster presentations at ACS and MRS National Meeting

Undergraduate Research Award

President Chemistry Club

Oral presentation ACS National Meeting