

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.
University of New Orleans: Chemistry, B.S.
Regulatory Affairs Professional Society: Devices, R.A.C.
Texas A&M: Business, M.B.A.
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:
- Drug for Male Testosterone
- Drug for Endometriosis
- Drug for Uterine Fibroids
- Drug for Vaginal Atrophy
- Drug for Colon Cancer
- Drug for COVID-19
- Drug- Oncolytic Virus
- Nutritional Supplement for Cystic Fibrosis (pediatric)
- Medical Device for Group B Streptococcus (pediatric)
- Medical Device for Asthma Monitoring (pediatric)
- Medical Device- IVD for Sepsis Detection
- Medical Device- Software for Sepsis Detection
- Medical Device for Gas Collection
- Medical Device for Urine Flow Measurement (pediatric)
- Medical Device for Spinal Fusion
- Medical Device for Neuromodulation (x4)
- Medical Device- Software for Wound Management
- Medical Device- Surgical Robot
- Medical Device- Vascularization imaging surgical device
- Medical Device- Catheter Guidewire
- Medical Device- Balloon Catheter
- Medical Device- Heart Valve (pediatric)
- Medical Device- Left Ventricular Assist Device (LVAD) or MCS (x4)
- Medical Device- Non-Invasive Blood Pressure Monitor (x3) (one pediatric)
- Medical Device- Software for Atrial Fibrillation Detection
- Medical Device- Biliary Catheter and Pump
- Medical Device- Software for Flow Cytometry Data Analysis
- Medical Device- Detection of Cerebral Blood Flow for Stroke Rehabilitation
- Medical Device- IVD for Melanoma Risk Assessment
- Medical Device- Anchors for Fetoscopic Surgeries (pediatric)
- Medical Device- Gastric Sleeve and Anchor
- Medical Device- Breast Localization Wire
- Medical Device- Gallbladder Cryoablation
- Medical Device- Noise attenuation for neonates (pediatric)
- Medical Device- Surgical margin detection device (x2)
- Medical Device- Organ Perfusion Device
- Medical Device- Perfusion Catheter
- Medical Device- Surgical Adhesion Material
- Medical Device- IVD for bacterial detection
- Medical Device- Sleep apnea relief
- Medical Device- Vascular patch
- Medical Device- Software for radiology
- Medical Device- Heart Rhythm management device
- Medical Device- Laboratory Robots
- Medical Device- Gastroscope (pediatric)
- Medical Device- Software for cancer management
- Medical Device- Software for autism treatment (pediatric)
- Medical Device- Intra-urethral valve pump and activator (x2) (pediatric)
- Medical Device- IVD for Barret’s Esophagus
- Medical Device- IVD for necrotizing enterocolitis (pediatric)
- Medical Device- Camera for ophthalmology
- Medical Device- Infusion pump
- Medical Device- Software for depressive disorder
- Medical Device- Stroke Cooling Device
- Medical Device- Ventilator
- Medical Device- IVD for COVID-19
- Medical Device- Infant feeding measurement device (pediatric)
- Medical Device- Software for attentional deficit disorders (pediatric)
- Medical Device- Diagnostic for ear infection (pediatric)
- Medical Device- Neonatal Incubator (pediatric)
- Medical Device- Scoliosis (pediatric)
- Medical Device- Intubation system
- Medical Device- Ultrasound surgical system
- Medical Device- Nasal spray delivery
- Medical Device- Coronary stent
- Medical Device- Epilepsy (pediatric)
- 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