Tara Gomez

About Tara Gomez

Used my hands as a PhD scientist at Caltech, before dropping the test tubes to explore product safety-first at Clorox then at Johnson & Johnson. All the while, finding any opportunity to build-in my passions for education, leadership, project management, and strategic process improvement within every role I\'ve held. Currently contributing to the cardiac electrophysiology innovation pipeline at JnJ MedTech, as a Medical Affairs professional. Responsible for providing safety design inputs and test plans for first-in-kind medical devices for the treatment of cardiac arrhythmias. Expertise in Medical and Regulatory Affairs, R&D, Pre-Clinical, Quality, Clinical, and Clin Ops. Participated in global regulatory submissions and clinical trial design to support product commercialization. Additionally, growing my local and global community through Directorship Board roles for non-profit organizations.

Experience

1. Director of Medical Affairs

   Johnson & Johnson MedTech

   Aug 2024 — Present

   VARIPULSE Medical Affairs lead• The primary and lead MA SME for the J&J’s first-of-its-kind pulsed field EP ablation catheterStrategize and conduct pre-clinical and clinical product evaluations• Led development of regulatory communications with WW HA’s to receive approvals for first-of-kind technology Strategize and conduct pre-clinical and clinical product evaluations• Executing Global launch strategy plans, evidence generation, and internal and external physician training• Created a project management function within the MA department to manage all product workstreams Publications: 1. Okumura, Y et. al, In vivo Assessment of Catheter-Tissue Contact using Tissue Proximity Indication and Its Impact on Cardiac Lesion Formation in Pulsed Field Ablation, Heart Rhythm 20242. Di Biase L, et al. Contraction sizing versatility of the variable-loop circular catheter for pulmonary vein isolation in atrial fibrillation: A subanalysis from the AdmIRE trial. Heart Rhythm.

Education

• Caltech

  PhD., Biology

  2006 — 2011

• UCLA

  B.S, Molecular, Cell, and Developmental Biology

  2001 — 2005

Skills

• Environmental Compliance
• Mass Spectrometry
• Biochemistry
• Research
• Databases
• Microscopy
• Process Improvements
• Compliance with U.s.-Based Legislative Requirements
• Gmp
• Dna
• Spanish
• Consumer Products
• U.s. Food and Drug Administration (Fda)
• Assay Development
• Laboratory
• Protein Chemistry
• Life Sciences
• R&D
• Chemistry
• Powerpoint
• Cell
• Regulatory Submissions
• Connecting with Enforcement Agencies
• Formulation
• Environmental Impact Assessment
• Fda
• Molecular Biology
• Sustainability
• Cell Culture
• Cell Biology
• Medical Devices
• Epa
• Regulatory Affairs
• Purification
• Protein Expression
• Genetics