Clinical Affairs Program Manager
📋 Role Overview & Responsibilities
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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This position is located in Irvine, CA with potential relocation and sponsorship assistance depending on candidate qualifications.
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