Regulatory Affairs Specialist (Innovation)
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Job Description
Description
The Regulatory Affairs Specialist (Innovation) is responsible for providing regulatory guidance, developing regulatory strategies, and conducting risk assessments, to new product development (NPD) teams for diagnostic (IVD) products. This position will be responsible for preparing FDA submissions, including, but not limited to: Pre-IDEs, PMA, PMA Supplements, De Novo Petitions, 510(k) submissions, and CLIA Waiver applications, as well as EU IVDR Technical Files/Dossiers.
Responsibilities:
Serves as Regulatory Affairs SME on various new product development (NPD) teams
Works cross-functionally with R&D, Medical Affairs, Quality, Marketing, Program Management and other key organizational functions
Recognizes and addresses potential regulatory risks with project plans
Responsible for organizing and leading various FDA & EU IVDR submissions
Serves as contact to FDA and Noti...