InDevR names new regulatory affairs director
“I am delighted to have Elizabeth join the team to help guide InDevR on regulatory submissions and compliance processes. Her experience and leadership skills will be a true asset as we work towards an FDA 510(k) submission for FluChip-8G,” InDevR CEO Kathy Rowlen said.
Malo will be managing the company's submissions and applications to various regulatory bodies, specifically the Food and Drug Administration. Her first projects will involve obtaining regulatory approval of the FluChip-8G in vitro diagnostic device.
Malo has worked in submission and applications for approximately 10 years. Previously she has assisted in development and commercialization regulatory processes for Covidien, Ventana Medical Systems and Biodesix.
She holds a master's degree in regulatory affairs for drugs, biologics and medical devices from Northeastern University in Boston.
The FluChip-8G is expected to be able to provide enhancements to the ability of doctors in hospitals and other health care facilities to be able to quickly determine a case of influenza and to be able to determine whether a case is a seasonal strain or a potential pandemic strain. The device's development was supported by the Biomedical Advanced Research and Development Authority (BARDA).