QA & Regulatory Affairs Lead – Life Sciences

Jobtailor; Naperville (IL); On-site; USD 110,000 - 160,000; Full time

Job summary

Jobtailor is seeking a senior Regulatory Affairs/Quality Assurance professional to lead compliance efforts across North America, ensuring CLIA/CAP/regulatory alignment and inspections readiness. You will manage audits, deviations, CAPAs, and regulatory submissions while supporting digital pathology initiatives.

The role emphasizes collaboration with cross-functional teams, documentation review, and ongoing process improvements to maintain quality and regulatory compliance in SaaS-based health

Qualifications

• Requires degree in Life Sciences or related field.
• 5+ years in quality assurance or regulatory affairs in regulated life sciences.
• Knowledge of US laboratory regulations (CLIA 42 CFR 493) and CAP requirements.

Responsibilities

• Implement and maintain compliance procedures across US and Canada.
• Coordinate post-market surveillance and regulatory submissions.
• Support FDA, CAP and CLIA inspections and audits.
• Drive continuous improvement and issue resolution with cross-functional teams.
• Prepare regulatory submissions and maintain regulatory documents.

Skills

Regulatory Compliance

Quality Audits

Root Cause Analysis

CAPA Management

Technical Documentation Review

Validation Activities Coordination

KPI Monitoring

Laboratory Operations Management

Digital Pathology Knowledge

ISO 13485 Standards

HIPAA compliance awareness

Education

Bachelor's degree or higher in Life Sciences/Clinical Laboratory Science/Computer Science or related field

Tools

Clinical Digital Pathology Software

Laboratory Information Management Systems

AI Technologies

Regulatory Requirements Database

Integrated Management System

Job description

Jobtailor is seeking a senior Regulatory Affairs/Quality Assurance professional to lead compliance efforts across North America, ensuring CLIA/CAP/regulatory alignment and inspections readiness. You will manage audits, deviations, CAPAs, and regulatory submissions while supporting digital pathology initiatives.

The role emphasizes collaboration with cross-functional teams, documentation review, and ongoing process improvements to maintain quality and regulatory compliance in SaaS-based health