Job Description

Job Duties Review medical scientific literature and analyze clinical risk to provide benefit/risk assessments. Write, review, and edit Clinical Evaluation Reports (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, and medical data. Prepare and update Safety Summary and Clinical Performance Reports (SSCPs) according to the SOP based on the CER and other sources, including the lay‑person summary. Write and update Clinical Evaluation Plans (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. Perform other duties as assigned. Minimum Requirements PhD degree in Biomedical Engineering or a related field. At least 1 year of experience writing and developing clinical documentation, planning and developing Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), and Safety Summary and Clinical Performance Reports (SSCPs). Experience applying 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. Job Location Lewisville, TX (Telecommuting permitted from anywhere in the U.S.). Equal Employment Opportunity Statement We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision‑making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws. This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment. #J-18808-Ljbffr

Job Tags

Similar Jobs