Responsible for global management and direction of all clinical and health care economics strategy and activity for diverse product portfolio.During tenure, we obtained Breakthrough designation, multiple investigation device exemptions (IDEs), new ICD-10 and CPT codes, and multiple FDA and worldwide regulatory approvals.

Founder of Right Submission, a SaaS based 510(k) submission, Clinical Study Report (CSR) and Clinical Evaluation Report (CER) platform acquired by EMERGO - UL.

Fifteen years of experience in biotechnology, including clinical operations, regulatory affairs, and quality assurance.Executive leadership in building and managing a premier clinical research organization targeted towards 505b2/IND/NDA/510(k)/IDE/PMA regulatory and clinical submissions for a wide array of therapeutic areas, including women's health, oncology, cardiovascular, orthopedics, general and plastic surgery and in-vitro diagnostics. Extensive experience involving medical device regulations, IND/NDA Regulatory submissions, Good Clinical Practices (GCP), Quality System Regulations (QSR), Good Clinical Data Management Practices (GCDMP), and Good Laboratory Practices(GLP).