Clinical Affairs Program Manager at JCW in Irvine, California

Posted in Other 10 days ago.

Type: full-time





Job Description:

Apply for an exciting opportunity to join a global Medical Device company. You will be writing many CERs for existing products in line with EU MDR guidelines and contribute to the clinical strategy for new products.
RESPONSIBILITIESCreate and manage detailed project schedule, timelines and project tracking tools for Clinical Evaluation, PMS and Post Market Clinical Follow-up (PMCF) processes for all medical devices and IVDs.Ensure, in conjunction with R&D and other personnel, that the clinical requirements of the product are adequately addressedManage relationship with CROs, as applicable
EXPERIENCEA minimum of 4 years of combined experience in clinical research, medical writing, clinical science in the medical device and/or pharmaceutical industry.Master's degree or Ph.D. preferred.Experience/knowledge in writing CERs and/or PMS plans in accordance with Meddev 2.12.2 and MDR
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