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Regulatory Specialist I

Company Name: ResearchDx, Inc.
Location: Irvine, CA
Job Type: Contract for hire (3 months) full time position starting ASAP
Email: To apply, please send your résumé and a short cover letter to This email address is being protected from spambots. You need JavaScript enabled to view it.
Website: http://www.researchdx.com

Job Description

Tasks:

Help with the management of clinical trials, medical device development, FDA submissions, and other projects. Example tasks may include:

  • Draft 510(k) and PMA pre-submissions and submissions
  • Develop / draft internal regulatory processes
  • Execute the regulatory aspects of design controls for product development
  • Execute the regulatory aspects of analytical and clinical validation for medical devices (GxP)
  • Carry out project management tasks for clinical trials and/or device development
  • Draft Study Plans, Reports, and other study documentation
  • Design specimen collection and shipping kits, Requisition Forms, etc.
  • Draft Lab Manuals for clinical trials
  • Perform sample receiving and accessioning
  • Carry out Quality Control of raw and / or processed data
  • Interact with sponsors, prepare electronic data transfers, etc.

Job Requirements

Minimum Requirements – Regulatory Specialist 1:

  • BS/MS with background or experience in biological/health sciences, especially molecular assays (e.g. qPCR, NGS, ELISA, etc.)
  • Some regulatory experience, especially with medical devices / IVD
    • 510(k) and PMA submissions (and pre-submissions)
    • GLP, GCP, GMP, ISO 13485, ISO 14971, and other relevant standards
    • Product development and design control
    • Clinical trial management and logistics
  • Capable of great attention to details (this job is all in the details)
  • Excellent verbal and written communication skills in English (critical)
  • Resourceful, good at finding out / working things out (within guidelines)
  • Must be able to work independently, after initial training

 To apply, please send your résumé and a short cover letter to This email address is being protected from spambots. You need JavaScript enabled to view it.