IVD Quality & Regulatory Lead - QMS & Compliance

True North Consultants, Inc.; Webster (TX); On-site; USD 110,000 - 170,000; Full time

Job summary

Our client in Houston, TX seeks a hands-on Quality and Regulatory Manager to lead QA/RA programs for IVD products, ensuring compliance with FDA, ISO 13485, and IVDR/IVDD. You will oversee the QMS, regulatory submissions, CAPA, and audits across manufacturing, R&D, and commercial activities.

The role requires a Bachelor's in life sciences or related field and 5+ years in QA/RA within biotech/biopharma or diagnostics, with strong communication and cross-functional collaboration skills.

Qualifications

• Bachelor’s degree in life sciences, chemistry, engineering, or related field.
• 5+ years QA/RA experience in biotechnology, biopharmaceuticals, or diagnostics, preferably IVD.
• Experience with FDA 21 CFR 820, ISO 13485, IVDR/IVDD regulations.

Responsibilities

• Lead and maintain the Quality Management System (QMS), ensuring compliance with 21 CFR Part 820, ISO 13485:2016, IVDR, IVDD, and other international standards.
• Serve as the Quality Management Representative and Person Responsible for Regulatory Compliance (PRRC), representing QA/Regulatory in projects and audits.
• Conduct and manage internal, customer, third‑party, and regulatory audits; track findings and implement corrective actions.
• Oversee manufacturing quality, CAPA, complaints, and nonconformance investigations, including root cause analysis and resolution.
• Develop and implement regulatory strategies for global IVD product submissions, registrations, and post‑market compliance.
• Drive process and product improvements through data analysis, risk assessments, and validation activities (IQ/OQ/PQ).
• Train staff on quality standards, maintain training records, and ensure cross‑functional adherence to regulatory and quality requirements.

Skills

QA/RA experience

FDA 21 CFR 820

ISO 13485

IVDR/IVDD

Regulatory submissions

Communication skills

Education

Bachelor’s degree in life sciences/chemistry/engineering

Job description

Our client in Houston, TX seeks a hands-on Quality and Regulatory Manager to lead QA/RA programs for IVD products, ensuring compliance with FDA, ISO 13485, and IVDR/IVDD. You will oversee the QMS, regulatory submissions, CAPA, and audits across manufacturing, R&D, and commercial activities.

The role requires a Bachelor's in life sciences or related field and 5+ years in QA/RA within biotech/biopharma or diagnostics, with strong communication and cross-functional collaboration skills.