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Regulatory Affairs Specialist I

  • Job reference: 933878
  • Location: West Sacramento, California
  • Salary: USD320 - USD344 per day
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 03/02/2021

We at Orion Group are currently recruiting a Regulatory Affairs Specialist I on behalf of one of our Multinational Medical Device Clients 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!

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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