A startup medical device company is looking for a regulatory affairs specialist experienced in the cardiac diagnosis market space. The primary task requires extraction of the user requirements from the FDA 510K summary report. The user requirements will then be used in our product development plan life cycle. The second task is to establish substantial equivalency through comparison of our product specifications
The task applies to Class II B hardware devices and Software as Medical Device (SaMD) projects.
5 freelancers are bidding on average $52/hour for this job
Hello, I'm a recent medical graduate currently catching my breath and working from home. I think I can live up to your expectations and look forward to hear from you. Thanks Parastoo