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Clinical Affairs Program Manager
- Posted: 12/04/2024
- Salary: Competitive
- Location: Orange County, California, United States
- Job Type: Permanent/Fixed Term
Opportunity to join a global Medical Device company, writing CERs for existing products in line with EU MDR guidelines, and contribute to the clinical strategy for new products.
Main Responsibilities
Main Responsibilities
- Create 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 addressed
- Manage relationship with CROs, as applicable
- A 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
Callum Sparkes
Director