Contract: Regulatory Affairs Specialist I / US

The client is currently recruiting a Regulatory Affairs Specialist I based in West Sacramento on a 10-month contract.

As a member of the Microbiology Quality & Regulatory Affairs department, your assignment will support key functional responsibilities, and compliance projects.

RESPONSIBILITIES:

• 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.
• Review and approval of updated labeling and literature in compliance with IVDR requirements.
• Support or prepare regulatory submissions, resolution of agency questions, and documents to secure market clearance and/or approval and appropriate country licenses and certificates for new products and/or changes to existing products.
• Prepare and manage registration, submissions, and technical documentation

EDUCATION AND EXPERIENCE:

• 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.

OTHER DESIRED SKILLS AND ABILITIES:

• In-depth knowledge of MicroScan product development and RA experience highly preferred.
• Experience with the IVDD/IVDR product requirements and 510(k) clearance process preferred.
• Microbiological Auto ID/AST products, hardware & software
• If you are interested, please get in touch!