Quality and Regulatory Manager

Location: Webster, TX | Schedule: Full-time, on-site

A life sciences platform supporting drug development, diagnostics, and therapeutic solutions through end-to-end services spanning discovery, manufacturing, and commercialization is seeking a hands-on Quality and Regulatory Manager to lead quality and compliance programs for IVD products. This role ensures regulatory compliance, drives product and process improvements, and supports continuous quality excellence across manufacturing, R&D, and commercial activities.

• 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.

• 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.
• Proficient in MS Office; able to travel as needed; eligible to work in the U.S.

• Familiarity with reagent and kit manufacturing preferred.
• QMS software experience a plus.

This position offers the opportunity to lead quality and regulatory strategy for IVD products across manufacturing, R&D, and commercial functions, serving as a key representative in audits and regulatory compliance initiatives.