IVD Quality & Regulatory Lead – Global Compliance
Listed on 2026-10-07
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Quality Assurance - QA/QC
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Healthcare
Software Placement Group is seeking a hands-on Quality and Regulatory Manager to lead QA/RA for IVD products, overseeing QMS, regulatory submissions, and audits across manufacturing, R&D, and commercial activities.
The role requires a Bachelor's in life sciences or related field and 5+ years of QA/RA experience, with strong knowledge of FDA 21 CFR 820, ISO 13485, IVDR/IVDD, and proven track record in regulatory submissions, CAPA, and process validation.
Our team is growing, and we are hiring a IVD Quality & Regulatory Lead – Global Compliance in Webster, TX, United States.
We appreciate your interest in this position.
Join Software Placement Group and contribute to our ongoing work.
Take a moment to read everything above and see whether this role is right for you.
This posting is for the IVD Quality & Regulatory Lead – Global Compliance role at Software Placement Group, based in Webster, TX, United States.
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