TPRG Jobs
TPRG IS ALWAYS LOOKING FOR TALENT TO COMPLEMENT THEIR EXPERT TEAM!
AVAILABLE NOW – MAY 2025:
Clinical Chemistry Regulatory Reviewer (Contractor / Consultant)
Remote | Project-Based | 510(k) Submissions
We’re seeking an experienced Clinical Chemistry expert with a strong understanding of FDA 510(k) submission requirements to support regulatory filings for in vitro diagnostic devices.
Responsibilities:
- Review clinical chemistry data, test performance protocols, summaries, test results and labeling for 510(k) submissions
- Ensure documentation meets FDA expectations (including analytical and clinical performance)
- Provide technical input on intended use, device description, and substantial equivalence rationale
Qualifications:
- Minimum of a bachelor’s degree in physical sciences, life sciences, pharmacy or engineering, which includes 30 semester hours in chemistry
- Strong Background in Clinical Chemistry, Laboratory Science, or related field
- Experience reviewing/auditing 510(k) submissions (especially IVD or laboratory instrumentation)
- Knowledge of FDA guidance documents, CLIA categorizations, and performance standards
- Detail-oriented with strong regulatory writing and communication skills
This is an ideal opportunity for a regulatory scientist or clinical chemist with FDA, industry, or consulting experience looking for flexible work on meaningful projects.
If interested, please email your resume and contact information to TPRG at info@fdathirdpartyreview.com.