EVIIVE is seeking a motivated Regulatory Affairs Lead to guide our diagnostic platform through early clinical and in-house IVD regulatory pathways. You will lead documentation for Swiss IvDO compliance, support QMS implementation, and prepare submissions for IVDR and FDA pathways.
You will define strategy across CH/EU/US, draft essential regulatory docs, and interact with Swissmedic and Notified Bodies while collaborating with clinical partners to accelerate real-world impact.
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