Regulatory Review Assistant

Job Summary

A company is looking for a Regulatory Review Assistant to support the Associate Lab Director and CLIA Laboratory Director in regulatory compliance and document management.

Key Responsibilities

• Assist in preparing validation documents and forms for license renewals
• Learn and support compliance with CAP/CLIA/NYS checklists and FDA LDT regulations
• Maintain organization of regulatory records and assist in proficiency testing collection

Required Qualifications, Training, and Education

• BS or MS in Biological Sciences
• Familiarity with NYS Clinical Lab Evaluation Program and/or CAP regulations
• Experience in Next Generation Sequencing and other molecular techniques
• Proficiency in Microsoft Office applications
• Some understanding of genetic testing methods