Current project: platelet derived exosomes (regenerative medicine)Previous support: freeze dried plasma, drug coated balloons, animal tissue derived hemostatic devices, variety of catheters and retrieval devices, small molecule solid oral.Sr. Regulatory Affairs Director who provides pathway options for biologics, drugs, devices, or combination products. Partners with cross functional teammates to select pathway and drive it across the finish line. M.S. in Regulatory Affairs (device emphasis) and Regulatory Affairs Certified (RAC). Laboratory and QA Technical Writing background prior to years spent in Regulatory. Professional development with IDE, IND, PMA, 510k, Design Dossier/Drug Consult File, BLA (including blood components), NDAs, ANDAs, OTC, Dietary Supplements, Rx Dietary Supplements, and Cosmetics.