Contract: Regulatory Affairs Specialist I / US
|Location:||West Sacramento, California, US|
|Salary:||USD320 - USD344 per day|
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.
- 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!