IVD Quality & Regulatory Lead – Global Compliance

Software Placement Group; Webster (TX); On-site; USD 110,000 - 170,000; Full time

Job summary

Software Placement Group is seeking a hands-on Quality and Regulatory Manager to lead QA/RA for IVD products, overseeing QMS, regulatory submissions, and audits across manufacturing, R&D, and commercial activities.

The role requires a Bachelor's in life sciences or related field and 5+ years of QA/RA experience, with strong knowledge of FDA 21 CFR 820, ISO 13485, IVDR/IVDD, and proven track record in regulatory submissions, CAPA, and process validation.

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

Responsibilities

• Lead and maintain the Quality Management System (QMS) and ensure compliance with 21 CFR Part 820, ISO 13485:2016, IVDR, IVDD.
• Act as Quality Management Representative and PRRC in projects and audits.
• Conduct internal, customer, third-party, and regulatory audits; track findings and implement corrective actions.
• Oversee manufacturing quality, CAPA, complaints, and nonconformance investigations; perform root cause analysis.
• Develop 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 and maintain training records; ensure cross-functional adherence to requirements.

Skills

Quality Management System

Regulatory compliance

Audits

CAPA

Root cause analysis

Data analysis

Regulatory submissions

Cross-functional communication

Education

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

Tools

MS Office

QMS software

Job description

Software Placement Group is seeking a hands-on Quality and Regulatory Manager to lead QA/RA for IVD products, overseeing QMS, regulatory submissions, and audits across manufacturing, R&D, and commercial activities.

The role requires a Bachelor's in life sciences or related field and 5+ years of QA/RA experience, with strong knowledge of FDA 21 CFR 820, ISO 13485, IVDR/IVDD, and proven track record in regulatory submissions, CAPA, and process validation.