Senior Research Scientist - IVD Product Clinic trail experience

Responsibilities:

A Senior Research Scientist (IVD) with clinical trial experience is typically responsible for designing, conducting, and analyzing clinical studies that demonstrate the performance of diagnostic assays and instruments. These studies are essential for regulatory submissions (e.g., FDA 510(k), EUA, CE-IVDR, NMPA registration).

• Develops clinical protocols in accordance with FDA, CLIA, ISO 13485 and IVDR requirements.
• Defines inclusion/exclusion criteria, sample size, study endpoints, and comparator/reference methods.
• Works closely with Clinical Affairs or CROs (Contract Research Organizations).

• Oversees clinical testing for sensitivity, specificity, accuracy, reproducibility, and precision.
• Collects and manages patient samples (prospective or retrospective).
• Performs data analysis to demonstrate “substantial equivalence” for 510(k) submissions.

• Prepares clinical sections of FDA 510(k), EUA, or IVDR Technical Files.
• Supports responses to regulatory questions (deficiency letters, additional information requests).
• Ensures all study activities comply with Good Clinical Practice (GCP) and Quality Management Systems (QMS) under ISO 13485.

• Works with R&D to refine assay design and performance claims.
• Partners with Regulatory Affairs, Biostatistics, and QA to ensure data integrity and traceability.
• Coordinates site training and monitoring visits.

• For CE/IVDR products, contributes to ongoing clinical evidence collection after commercialization.

• Medical Insurance Plan
• Retirement Plan
• Paid Time Off

• Training & Development
  
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