QA RA Specialist

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

• Implement and maintain procedures meeting OIG, CLIA, CAP, federal and state regulations


• Ensure quality and integrity of test data, laboratory operations and services across North American clinical operations


• Own and execute internal, vendor and supplier quality audits


• Manage planned deviations, non-conformances, CAPAs, change management and the risk register


• Manage incidents through triage, escalation, investigation and root cause analysis


• Maintain inspection readiness and support FDA, CAP and CLIA inspections and audits


• Coordinate validation activities for clinical workflows, sites and scanners


• Provide QA input on document reviews, supplier management, information security and data privacy


• Support client audits and coordinate post-audit activities


• Provide quality metrics for KPI monitoring and trend analysis


• Support the laboratory safety programme


• Drive continuous improvement and resolve quality issues with cross-functional teams


• Develop and implement regulatory plans, strategies and compliance plans for clinical digital pathology products and services in the US and Canada


• Compile and review technical documentation for regulatory submissions


• Prepare submissions for FDA, CMS-CLIA-LDT, CAP and SCC applications


• Support communications with regulatory authorities, Notified Bodies and Competent Authorities


• Coordinate post-market surveillance and submit periodic regulatory reports


• Monitor US, Canadian and emerging regulatory requirements and conduct gap analyses and impact assessments


• Maintain the regulatory requirements database and Regulatory Affairs intranet


• Ensure compliance with HIPAA, GDPR and information security requirements


• Develop policies and procedures and integrate regulatory requirements into the Integrated Management System


• Review marketing materials and change requests affecting regulatory or customer filings


• Participate in leadership meetings and provide QA/RA input


• Deliver quality and regulatory training


• Travel internationally occasionally, approximately 10%

Requirements

• Bachelor's degree or higher in Life Sciences, Clinical Laboratory Science, Computer Science or a related field


• At least 5 years' experience in a quality assurance and/or regulatory affairs role within a regulated life science, clinical services or medical device environment


• Strong knowledge of US laboratory regulations, including CLIA 42 CFR 493 and CAP General Laboratory, Anatomic Pathology and proficiency testing requirements


• Working knowledge of FDA regulations applicable to clinical digital pathology, including 21 CFR 820


• Strong communication, collaboration and stakeholder management skills, including technical report writing


• Strong analytical and problem-solving skills


• Ability to work independently and manage multiple priorities and deadlines


• Experience managing a CAP laboratory accreditation programme, or certification/professional training in CLIA/CAP laboratory accreditation or regulatory affairs


• Experience with Software as a Medical Device (SaMD) and medical device regulation


• Experience with US and Canadian regulatory frameworks for SaaS products and clinical services


• Experience with digital pathology scanning equipment and software systems, AI technologies and emerging AI standards, and/or pathologist licensing and credentialing


• Experience with laboratory billing practices, Stark Law, anti-kickback and anti-markup rules


• Experience with recognised quality management systems or standards such as ISO 13485, ISO 15189:2022 or equivalent


• Must complete mandatory company and job-specific training, including ISMS, DocuSign, SDLC and GDPR/HIPAA awareness, as applicable

Core Competencies

Demonstrates expertise in regulatory affairs and quality assurance within the life sciences sector, with a strong focus on compliance with US and Canadian laboratory regulations, including CLIA and CAP. Proficient in managing quality audits, incident investigations, and regulatory submissions while driving continuous improvement initiatives.

Highest-signal resume keywords

• Quality Assurance Management


• Regulatory Affairs Expertise


• FDA Regulations Knowledge


• CLIA/CAP Accreditation Experience


• Analytical Problem-Solving Skills

Hard 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

Soft Skills

• Strong Communication Skills


• Collaboration Skills


• Stakeholder Management


• Analytical Skills


• Problem-Solving Skills

Certifications & Qualifications

• CLIA Certification


• CAP Certification


• Regulatory Affairs Certification

Industry Keywords

• Life Sciences


• Clinical Services


• Medical Device Regulation


• SaaS Products


• HIPAA Compliance


• GDPR Compliance


• Laboratory Billing Practices


• Stark Law


• Anti-Kickback Rules


• Quality Management Systems

Tools & Technologies

• Clinical Digital Pathology Software


• Laboratory Information Management Systems


• AI Technologies


• Regulatory Requirements Database


• Integrated Management System