IVD Quality & Regulatory Leader

KingRecruitingServices; Webster (TX); Hybrid; USD 125,000 - 180,000; Full time

Job summary

The Quality and Regulatory Manager will lead the quality management system and regulatory compliance programs for IVD products in Houston, TX. You will drive regulatory submissions, CAPA programs, audits, and product/process improvements across manufacturing, R&D, and commercial functions.

Ideal candidates hold a life sciences-related bachelor's degree and have 5+ years in QA/RA for biopharma, diagnostics, or IVD, with strong knowledge of FDA and ISO regulations and experience in regulatory

Qualifications

• Bachelor's degree in life sciences, chemistry, engineering, or related field.
• 5+ years QA/RA experience in biotech/diagnostics, preferably IVD.
• Strong knowledge of FDA 21 CFR 820, ISO 13485, and EU IVDD/IVDR.
• Medical device experience is required; pharmaceutical experience is not applicable.
• Experience with regulatory submissions, CAPA, root cause analysis, and validation.
• Detail-oriented, analytical, and able to communicate across teams.
• QMS software experience a plus; willingness to travel; eligible to work in the U.S.

Responsibilities

• Lead and maintain the 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

Regulatory submissions

FDA 21 CFR 820

ISO 13485

IVDR/IVDD familiarity

Audit management

Education

Bachelor's degree in life sciences/chemistry/engineering

Tools

QMS software

MS Office

Job description

The Quality and Regulatory Manager will lead the quality management system and regulatory compliance programs for IVD products in Houston, TX. You will drive regulatory submissions, CAPA programs, audits, and product/process improvements across manufacturing, R&D, and commercial functions.

Ideal candidates hold a life sciences-related bachelor's degree and have 5+ years in QA/RA for biopharma, diagnostics, or IVD, with strong knowledge of FDA and ISO regulations and experience in regulatory