Quality & Regulatory Lead - IVD Medical Devices

Job Juncture; Webster (TX); On-site; USD 120,000 - 160,000; Full time

Job summary

Job Juncture seeks a hands-on Quality and Regulatory Manager in Houston, TX to lead QA/RA programs for IVD products and ensure compliance with 21 CFR 820, ISO 13485, and IVDR/IVDD across manufacturing, R&D, and commercial activities.

The ideal candidate holds a life sciences-related degree, 5+ years in QA/RA for biotech/diagnostics, and proven regulatory submissions, CAPA, and validation experience. Travel and cross-functional collaboration are essential.

Qualifications

• Bachelor’s degree in life sciences, chemistry, engineering, or related field.
• 5+ years QA/RA experience in biotechnology, biopharmaceuticals, or diagnostics, preferably IVD.
• Strong knowledge of FDA 21 CFR 820, ISO 13485, and EU IVDD/IVDR regulations.
• Medical device experience is required; pharmaceutical experience is not applicable.
• Experience in regulatory submissions, CAPA, root cause analysis, and process validation.

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 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

Attention to detail

Analytical thinking

Communication

Education

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

Tools

MS Office

QMS software

Job description

Job Juncture seeks a hands-on Quality and Regulatory Manager in Houston, TX to lead QA/RA programs for IVD products and ensure compliance with 21 CFR 820, ISO 13485, and IVDR/IVDD across manufacturing, R&D, and commercial activities.

The ideal candidate holds a life sciences-related degree, 5+ years in QA/RA for biotech/diagnostics, and proven regulatory submissions, CAPA, and validation experience. Travel and cross-functional collaboration are essential.