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 [email protected].