Regulatory Affairs Innovator - IVD & FDA Submissions
RXinsider LTD.
Waters is seeking a Regulatory Affairs Specialist (Innovation) to provide regulatory guidance, develop strategies, and conduct risk assessments for new product development (IVD devices, automated laboratory systems, and software). This role coordinates FDA submissions (Pre-IDEs, PMA, PMA Supplements, De Novo Petitions, 510(k)) and EU IVDR dossiers, partnering with R&D, Quality, Medical Affairs, and Marketing to drive compliant, innovative solutions in a fast-moving healthcare tech environment. #J-18808-Ljbffr RXinsider LTD.
Vacancy posted 4 days ago
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