The Rogosin Insitute, a non-profit organization developing new therapeutics for Cancer and Diabetes is seeking an experienced Compliance Manager to join our team in Xenia, Ohio. this position will be hands on support for our early Phase I and Phase II clinical trials involving the production and scale up of our biological therapeutic devices. This candidate will provide guidance on FDA regulatory compliance as it relates to Medical/Biological Devices. The candidate will work independantly with the production teams to ensure continuous improvement of quality systems and cGMP compliance. Occasional travel is required. Salary is negotiable.
This position requires a BS/BA degree in Biological Sciences or a related field. An advanced degree is a plus. Any regulatory certifications/credentials would be an added plus. Candidate must have previous experience in an FDA regulated environment and a thorough understanding of cGMPs, cGLPs, and GXPs in general. Please e mail a cover letter and curriculum vitae with salary history in confidence to diabetes@rixd.org