Melodie Domurad
About Melodie Domurad
Melodie Domurad VP, Clinical and Regulatory Affairs
Melodie Domurad holds the position of Vice President of Clinical and Regulatory Affairs. With an extensive career spanning over 25 years, she has led the development, design, and implementation of phase I-IV clinical trials related to In Vitro Diagnostics (IVDs) and therapeutic devices. Her experience is marked by her role as an architect of multiple successful regulatory submissions to various authorities including the FDA and international bodies. These submissions encompass a range of designations such as IDE, 510(k), de novo, PMA, and CE.
Melodie Domurad Education and Expertise
Melodie Domurad holds a Bachelor of Arts (BA) degree from Cornell University. Further advancing her education, she earned a Doctor of Philosophy (PhD) degree from the University of Cincinnati. Her high level of academic achievement underpins her expertise in clinical and regulatory affairs, making her a vital asset in the field of clinical trials and regulatory submissions for IVDs and therapeutic devices.
Melodie Domurad Clinical Trials Experience
Melodie Domurad boasts more than 25 years of experience in the development, design, and implementation of phase I-IV clinical trials. Her work primarily focuses on In Vitro Diagnostics (IVDs) and therapeutic devices. Through her extensive knowledge and hands-on involvement in clinical trials, she has significantly contributed to advancing these fields by ensuring that new products meet clinical and regulatory standards.
Melodie Domurad Regulatory Submissions
Throughout her career, Melodie Domurad has been the architect behind multiple successful regulatory submissions. She has successfully navigated the complex requirements of the FDA and international authorities, producing submissions for IDE, 510(k), de novo, PMA, and CE certifications. Her expertise in regulatory affairs has been instrumental in obtaining the necessary approvals for introducing new medical devices to the market.