Job Details
Job Description
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).
Clinical Study Design & Protocol Development
- 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). Clinical Performance Evaluation (CPE)
- 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.
Regulatory Submission Support
- 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.
Cross-Functional Collaboration 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.
Post-Market Clinical Follow-Up (PMCF) For CE/IVDR products, contributes to ongoing clinical evidence collection after commercialization. Master's degree in a relevant scientific discipline (e.g., Materials Science, Chemistry, Biochemistry, or related field). 3 to 5 years of hands-on experience in research and development, with a focus on materials for the IVD industry.
Proven expertise in material characterization techniques, experimental design, and statistical analysis. Familiarity with regulatory requirements for IVD products and experience in contributing to regulatory submissions. Strong collaboration and communication skills, both within cross-functional teams and with external partners.
- Demonstrated ability to lead projects, drive innovation, and contribute to the advancement of IVD materials.
Medical Insurance Plan Retirement Plan Paid Time Off
- Training & Development
We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or
