IVD Quality & Regulatory Lead—QMS, Audits, Compliance

Sora Resource Group; Webster (TX); On-site; USD 120,000 - 170,000; Full time

Job summary

Sora Resource Group is seeking a hands-on Quality and Regulatory Manager to lead QA/RA programs for IVD products in Houston, TX. You will drive regulatory submissions, audits, CAPA, and product/process improvements across manufacturing, R&D, and commercial teams.

The role requires experience with FDA 21 CFR 820, ISO 13485, EU IVDR/IVDD, and QMS governance while supporting global regulatory strategies and cross-functional training.

Qualifications

• Bachelor’s degree in life sciences, chemistry, engineering, or related field.

Responsibilities

• Lead and maintain the QMS, ensuring compliance with 21 CFR Part 820, ISO 13485:2016, IVDR, IVDD.

Skills

QA/RA experience

Regulatory compliance

Regulatory submissions

CAPA & root cause analysis

Process validation

Data analysis

Communication across teams

MS Office

Travel willingness

PRRC knowledge

Education

Bachelor’s degree in life sciences, chemistry, engineering, or related field

Tools

QMS software

MS Office

Job description

Sora Resource Group is seeking a hands-on Quality and Regulatory Manager to lead QA/RA programs for IVD products in Houston, TX. You will drive regulatory submissions, audits, CAPA, and product/process improvements across manufacturing, R&D, and commercial teams.

The role requires experience with FDA 21 CFR 820, ISO 13485, EU IVDR/IVDD, and QMS governance while supporting global regulatory strategies and cross-functional training.