Position Overview
About Essenlix Corporation:
Essenlix Corporation is a fast-growing medical device company focused on developing innovative point-of-care (POC) diagnostic systems, including hematology analyzers and disposable cartridges for complete blood count (CBC) testing.
Our overseas manufacturing facility in China is ISO 13485 certified. We are strengthening our U.S. -based quality management system and integrating global operations as we transition from development to commercialization in preparation for FDA clearance and international market expansion.
Position Summary:
We are seeking an experienced Senior Regulatory Affairs & Quality Systems Manager to lead FDA 510(k) and CLIA submissions and global quality system development.
Key Responsibilities:
Regulatory Affairs:
- Lead preparation and submission of FDA 510(k) appli...