Lewisville, TX22 days ago
Job Duties: Review medical scientific literature, analyze clinical risk and provide benefit/risk assessments, write, review, and edit CERs to comply with international regulations; write and update coherent and convincing CERs and PMCF Reports by organizing and evaluating large amounts of scientific/clinical/medical data; prepare and update SSCPs, according to the SOP, based on the CER and other sources, including the part for lay persons; write and update CEPs and PMCF plans; work collaboratively with cross-functional partners; prepare answers to Notified Body or Regulatory Agency requests; assist with other clinical, marketing, and regulatory projects as assigned (including: preparation of IFU and PSUR); acquire, interpret, analyze, and draw conclusions from clinical data from clinical trials, literature, and experiences for a wide variety of medical devices; communicate scientific content in a clear and concise manner; mentor and train new incoming team members about procedures and best practices; and, perform other duties as assigned. Telecommuting permitted form anywhere in the U.S. Minimum Requirements: PhD degree in Biomedical Engineering or related field and 1 year of experience writing and developing clinical documentation, planning and developing clinical evaluation reports (CERs), clinical evaluation plans (CEPs) and summary of safety and clinical performance reports (SSCPs); working on clinical documents for global product registrations and continued market access; conducting systematic literature searches in PubMed, EMBASE, or other relevant platforms; and using citation management software.