Regulatory Specialists, multiple positions

Company: ResearchDx, Inc.

Position: Regulatory Specialist 1, 2, or 3

Location: Irvine, CA

Posted: August 9, 2021

Regulatory Specialists, multiple positions

 

ResearchDx is the leading Contract Diagnostics Organization (CDO) to the In Vitro Diagnostics (IVD) development industry with experience in all aspects of IVD development from product design, through program, project and study design, initiation, execution, and documentation, to implementation into the CLIA laboratory environment and/or FDA submissions. We have at least two immediate, urgent openings for full-time Regulatory Specialists, both in early career and with a solid experience in medical diagnostics, to join our Clinical Research Services team.

 

Minimum Requirements – Regulatory Specialist (level 1, 2 or 3; will be commensurate with experience):

  • BS/MS with background or experience in biological/health sciences, especially molecular assays (e.g. qPCR, NGS, ELISA, etc.)
  • One to 3 years (junior) or 4+ years (senior) of regulatory experience with medical devices / IVD
    • 510(k) and PMA submissions (and pre-submissions)
    • GLP, GCP, GMP, ISO 13485, ISO 14971, IVDR, and other relevant standards
    • Product development and design control
    • CAPA, NCR, Change Control, etc.
    • Clinical trial management and logistics
  • Capable of great attention to details (these jobs are all in the details)
  • Excellent verbal and written communication skills in English (critical; writing must be impeccable)
  • Resourceful, good at finding out / working things out (within guidelines)
  • Must be able to work independently, after initial training

 

Tasks:

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

  • Draft 510(k) and PMA pre-submissions and submissions
  • Execute the regulatory aspects of design controls for product development
  • Execute the regulatory aspects of analytical and clinical validation studies for medical diagnostics (GxP)
  • Draft Study Plans, Reports, Product Requirements, Risk Management, and other study documentation
  • Support the reporting of lab events, CAPA, controlled changes, etc.
  • Carry out project management tasks for clinical trials and/or device development
  • Design specimen collection and shipping kits, Requisition Forms, CRF, ICF, etc.
  • Draft Lab Manuals for clinical trials; site training, management and monitoring
  • Carry out Quality Control of raw and / or processed data
  • Interact with sponsors, prepare electronic data transfers, etc.
  • Develop / draft internal regulatory processes (e.g. to maintain compliance or improve process efficiency)

 

Location and work conditions:

  • Location: ResearchDx, Inc. main facility in Irvine, CA (see researchdx.com)
  • Reporting to the Vice President, Clinical Research Services
  • These are full-time positions, starting ASAP
  • To apply, please send your résumé and a short cover letter to lferland@researchdx.com.