San Antonio, Texas Director of Regulatory Affairs (Med Device)
The Newell Group is recruiting on behalf of an innovative, rapidly-growing biotech firm in the San Antonio, TX or Philadelphia, PA for
Regulatory Affairs Director
Successful senior candidates will have experience leading teams through the FDA regulatory process for Medical Devices
All candidates will have experience with
510K, RFD, FDA 21, CFT 820, UDI and other regulations in the context of biomed/med device products
TRF, RFD, UDI
CAPA, QA, Supplier Management
Degree in Biological sciences or closely related field required- Master’s Preferred.
Candidates whose primary experience is in pharmaceuticals or who hold degrees in regulatory affairs are respectfully informed that this is not the experience needed for this role.
In addition to a competitive base, these roles include bonus, health, vision, dental and other benefits.
This role can be based in San Antonio, TX or Philadelphia, PA with some travel between sites.