Regulatory Affairs Specialist (Innovation)
Core
Provide regulatory guidance, develop strategies, and conduct risk assessments for new product development teams on in vitro diagnostic (IVD) devices, automated laboratory systems, and related software.
Role type
Regulatory Affairs Specialist (Innovation)
Builds
FDA submissions (Pre-IDEs, PMA, De Novo, 510(k), CLIA Waivers) and EU IVDR Technical Files/Dossiers for IVD and lab systems.
Domain
Life Sciences / Medical Devices / In Vitro Diagnostics
Deliverable
client delivery
Required skills
Regulatory strategy development, FDA submission preparation, EU IVDR dossier compilation, risk assessment, cross-functional coordination, regulatory lifecycle management
Preferred skills
Complex regulation interpretation, advanced technical/scientific principles understanding, primary authorship of regulatory submissions, digital health or software regulatory experience
Technologies
Microsoft Office (Excel, Word, PowerPoint)
Responsibilities
Serve as Regulatory Affairs SME on new product development teams; organize and lead FDA & EU IVDR submissions; act as contact for FDA and Notified Body review teams; identify and address regulatory risks in project plans; propose continuous process improvements.
Seniority
Mid-level, hands-on IC
