As a member of the Microbiology Quality & Regulatory Affairs department, your assignment will support key functional responsibilities, and compliance projects. Performs regulatory affairs functional responsibilities in support of new product development and commercialization. Support Regulatory Affairs for IVDR project tasks such as review and approval of clinical summaries; creation, assembly, and review of STED documents.
Requirements of the Regulatory Affairs Specialist:
- Bachelor’s degree in field with +2 years exp. OR Master’s degree in field with 0-2 years of experience working with regulatory requirements and agencies; specifically, FDA, IVDD and ISO 13485 required.
- In-depth knowledge of MicroScan product development and RA experience
- Experience with the IVDD/IVDR product requirements and 510(k) clearance process
- Microbiological Auto ID/AST products, hardware & software
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