Quality and Regulatory Manager

The Keystone Distinction Group; Webster (TX); On-site; USD 110,000 - 150,000; Full time

Job summary

We’re seeking a hands‑on Quality and Regulatory Manager to lead quality and compliance programs for IVD products in Houston, TX. This role ensures regulatory compliance, drives product and process improvements, and supports continuous quality excellence across manufacturing, R&D, and commercial activities.

Responsibilities include maintaining the QMS, serving as PRRC, coordinating audits, and developing regulatory strategies for global submissions and post‑market compliance.

Qualifications

• Bachelor’s degree in life sciences, chemistry, engineering, or related field.
• 5+ years QA/RA experience in biotechnology, biopharmaceuticals, or diagnostics, preferably IVD.
• Knowledge of FDA 21 CFR 820, ISO 13485, EU IVDR/IVDD regulations.
• Medical device experience is required; pharmaceutical experience is not applicable.
• Experience with regulatory submissions, CAPA, root cause analysis, and process validation.
• Strong communication and cross-team collaboration skills.
• Familiarity with reagent and kit manufacturing; QMS software experience is a plus.
• Proficient in MS Office; able to travel; eligible to work in the U.S.

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

QA/RA experience

FDA regulations knowledge

Regulatory submissions

Audits

Education

Bachelor's degree in life sciences/chemistry/engineering

Tools

QMS software

MS Office

Job description

We’re seeking a hands‑on Quality and Regulatory Manager to lead quality and compliance programs for IVD products for our client in Houston, TX. This role ensures regulatory compliance, drives product and process improvements, and supports continuous quality excellence across manufacturing, R&D, and commercial activities.

Our client, a life sciences platform is accelerating innovation across drug development, diagnostics, and therapeutic solutions by offering end-to-end services—from early-stage discovery through manufacturing, commercialization, and delivery. The organization’s network includes several specialized subsidiaries providing custom chemicals, reagents, assays, lipid nanoparticle design, immunoassay development, diagnostic tools, and STEM education solutions.

Requirements of the Quality and Regulatory Manager:

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

Responsibilities of the Quality and Regulatory Manager:

• 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.

Occupational category: 11-9199.01 - Regulatory Affairs Managers