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Regulatory Affairs Specialist

Company: Kelly Services
Location: West Sacramento
Posted on: April 9, 2021

Job Description:

Kelly Services-- has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Regulatory Affairs Specialist at a prestigious Fortune 500-- company working in West Sacramento, CA.----Important information:--This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the "Submit Resume" button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position () however your resume must be received via the "Submit Resume" button included within.--Job Title: Regulatory Affairs Specialist--Pay: $41.39 per hour--Remote position that will move onsite. M-F 8:00AM - 5:00PM----------------------------------------------------------------------Position SummaryAs 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.--Requirements: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----We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: .Kelly Services-- is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.Kelly Services is an Equal Opportunity Employer----Why Kelly--?Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]]

Keywords: Kelly Services, West Sacramento , Regulatory Affairs Specialist, Other , West Sacramento, California

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