ABOUT ORGANOX:
OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company's first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally. Position Summary The Regulatory Affairs Medical Writer supports regulatory submissions and clinical documentation by generating and maintaining regulatory deliverables that incorporate clinical data, scientific literature, and regulatory rationale. This role reports directly to the Regulatory Affairs Manager and collaborates with Clinical Affairs and other cross-functional teams. The successful candidate will contribute to the preparation of Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and documentation in support of IDE applications and regulatory submissions to Notified Bodies, the FDA, and other global agencies. This role requires a strong foundation in scientific research, medical writing, and familiarity with regulatory requirements including EU MDR and FDA regulations. This is an onsite position in Madison, NJ and will require periodic travel to the UK and other locations. Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive. Major Responsibilities Under direction from the Regulatory Affairs Manager, the Regulatory Affairs Medical Writer will be responsible for: Regulatory Medical Writing Support...Comply with all Federal and Local rules and regulations regarding driving and load securement. Notice any damage on rental units when... ...customer needs Experience/Education: ~3 to 5 years' experience CDL A. Combination of education and experience may be considered in...
Research Software Engineer Location Baltimore, MD : The Johns Hopkins Data Science and AI Institute (DSAI) is a new pan-institutional initiative at Johns Hopkins to advance artificial intelligence and its applications, in part through investments in the software engineering...
Full Time - Hiring ImmediatelyThis is a Unionized Facility Shift: Night Schedule 12-hr midnight shift, 11p-11a (Monday - Friday) Saturdays as needed. Training can be on steady daylight (11a) or steady midnight (11p) through probation which is 10-12 weeksWhat we offer...
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