Job Description:
Our client is seeking a skilled regulatory professional with expertise in the de Novo classification / pathway for an IVD to provide insight for building a de novo path overview, regulatory strategy, competitive landscape, requirements, etc. one of the client’s products. The product is a type of wound care related device currently submitted through a 510(k) based on predicate devices. However, the client is interested in evaluating the possibility of adding a new claim which is not yet included on any of the predicate devices on the market. The claim would relate to anti-biofilm activity. The consultant would utilize their previous experience/expertise to create an overview of the process, a potential regulatory strategy for the pathway, help the client to build the case for de novo classification and summarize competitive landscape.
Remote: DeNovo Regulatory Consultant (237453)
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