Quality & Regulatory Lead, IVD Medical Devices

H. T. PROF Group; Webster, Northern (TX, KY); Hybrid; USD 110,000 - 160,000; Full time

Job summary

H. T. PROF 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 compliance, support continuous quality improvements across manufacturing, R&D, and commercial activities, and coordinate cross-functional teams. The role requires 5+ years in QA/RA within biotech/diagnostics, strong knowledge of 21 CFR 820, ISO 13485, IVDR/IVDD, and experience with regulatory submissions and CAPA.

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.
• Detail-oriented, analytical, and able to communicate effectively across teams.
• Familiarity with reagent and kit manufacturing preferred; QMS software experience a plus.

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).
• 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

Regulatory compliance

Quality management

Audit coordination

CAPA & root cause analysis

Regulatory submissions

Cross-functional communication

MS Office

Education

Bachelor’s degree in life sciences/chemistry/engineering

Tools

QMS software

Job description

H. T. PROF 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 compliance, support continuous quality improvements across manufacturing, R&D, and commercial activities, and coordinate cross-functional teams. The role requires 5+ years in QA/RA within biotech/diagnostics, strong knowledge of 21 CFR 820, ISO 13485, IVDR/IVDD, and experience with regulatory submissions and CAPA.