Job Description:
Our client is seeking a skilled regulatory professional with expertise in the preparation and filing of regulatory documentation for the drug/medicinal component of a Class III medical device. The product involves a cleansing solution with active ancillary effects designed to help remove micro-organisms. Previously, the client sourced this solution from another manufacturer, but they will now assume manufacturing responsibilities for the drug component. The consultant will be responsible for developing the filing from the ground up and ensuring compliance with all regulatory requirements, including chemical composition and characteristics, mode of action and pharmacological/toxicological effects, biocompatibility, risk-benefit analysis, and biological safety. Additionally, the consultant must ensure that the submission aligns with expectations for devices incorporating medicinal substances.
Remote: Class III Medicinal File (237454)
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