Regulatory & Quality Lead, Medical Devices; SaMD
Job in
Mission, Johnson County, Kansas, 66201, USA
Listed on 2026-08-30
Listing for:
Alva Health Inc.
Full Time
position Listed on 2026-08-30
Job specializations:
-
Healthcare
-
Quality Assurance - QA/QC
Job Description & How to Apply Below
Alva Health Inc. seeks a Medical Quality & Regulatory Specialist to establish and manage our QMS, support FDA/ISO submissions, and ensure SaMD compliance.
You will work closely with engineering to implement lifecycle controls, risk management, and documentation processes essential for our stroke-monitoring platform. You will contribute to preparing FDA submissions, maintaining traceability, and advancing the regulatory framework as we move toward FDA clearance and ISO certification in a
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