About the role
The team develops early cancer detection products using next-generation sequencing. The role involves leading scientists and managers to execute product development, verification, and validation studies. This includes generating data for regulatory submissions and serving as a technical expert in interactions with regulatory bodies.
Our summary of the posting; the original is on the Natera careers page.
What the posting requires
- Required
- Ngs
- FDA regulations
- Diagnostic assays
- 21 CFR Part 820
- Assay design
- QMSR
- Analytical validation
- ISO 13485
- Assay transfer
- Preferred
- Bioinformatics pipelines
- Companion software
- IEC 62304
- PMA submission
- Clinical validation studies
- LDTs
These tags are our reading of the posting. They can miss something; the original posting is the reference.