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
  • 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
Experience Required
  • 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

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