Location: Naperville, Illinois - hybrid role, 2/3 days per week on site
Type: Full-time, permanent
About this Role
We are seeking a QA/RA Specialist, Clinical, North America to join our Diagnexia team on-site in Chicago (hybrid role 2 or 3 days a week on site). This is a key role within the QA/RA Clinical group, responsible for ensuring that clinical laboratory operations, products and services across Diagnexia US and Diagnexia Canada meet the highest quality and regulatory standards. The successful candidate will bring combined expertise in quality assurance and regulatory affairs, acting as a single point of accountability for QA/RA matters across our North American clinical operations.
Responsibilities:
Quality Assurance
- Implement and maintain procedures to meet OIG, CLIA, CAP and federal and state regulations, working closely with Clinical Operations to ensure the quality and integrity of test data, laboratory and service activities at the Chicago site and across Diagnexia's North American clinical operations
- Own the internal Quality Audit programme, executing audits of in-house processes, systems and facilities as well as vendor and supplier audits, to ensure compliance with regulatory requirements and company standards
- Manage quality processes including planned deviations, non-conformances, corrective and preventive actions (CAPAs), change management and maintenance of the risk register
- Incident management including triage, escalation where needed, investigation and root cause analysis (eg 5 Whys)
- Ensure the clinical laboratory and services are inspection ready at all times, and support regulatory inspections and audits as required, including FDA, CAP and CLIA
- Coordinating validation activities for new/updated clinical workflows, sites and scanners, including protocol preparation, pathologist coordination, result review and compiling validation reports and supporting evidence.
- Provide QA input across document reviews, supplier management, information security and data privacy processes
- Support client audits of clinical processes and coordinate post-audit activities, working closely with client quality teams on training, audit coordination and client evaluation documents
- Provide routine quality metrics to management for KPI monitoring and trend analysis
- Support the laboratory safety programme
- Drive continuous improvement, collaborating with cross-functional teams to identify and resolve quality issues and implement process improvements in line with best practice, including CAP, CLIA and HIPAA
Regulatory Affairs
- Work with Clinical and Laboratory Operations, QA/RA, Commercial, Legal and R&D teams, in collaboration with the Director of QA/RA, Clinical, to develop, maintain and implement regulatory plans, strategies and compliance plans for clinical digital pathology products and services in the US and Canada, including AI-enabled technologies
- Compile and review technical documentation required for regulatory submissions for Diagnexia clinical digital pathology solutions in the US and Canada
- Make submissions for regulatory and accreditation applications for new and existing products and services, to project timelines, to applicable regulatory bodies including US federal and state agencies (FDA, CMS-CLIA-LDT) and Canada (CAP, SCC)
- Lead or support communications and engagement with regulatory authorities, Notified Bodies and Competent Authorities regarding regulatory submissions, licence and accreditation applications, vigilance and compliance activities
- Coordinate post-market surveillance (PMS) activities for clinical products and services, and write and submit periodic regulatory reports to authorities as required
- Monitor changes to US, Canadian and emerging regulatory requirements and standards, including FDA/LDT rule changes, AI regulation and privacy and security regulation, and conduct regulatory gap analyses and impact assessments to ensure ongoing compliance
- Maintenance of regulatory intranet
- Ensure compliance with applicable privacy and information security requirements, including HIPAA and GDPR
- Establish, manage and monitor the global regulatory requirements database, keeping the product portfolio in compliance with applicable regulations and assist in maintaining the Regulatory Affairs intranet site.
- Develop and maintain internal policies and procedures, and support the integration of regulatory requirements into the Integrated Management System (IMS), including change management, complaint handling, periodic document reviews, gap assessments and inputs to quality management reviews
- Review new marketing materials and change requests where these may impact regulatory or customer filings
General
- Participate in clinical and laboratory leadership meetings and provide quality and regulatory inputs
- Foster a culture of quality and compliance within clinical operations
- Deliver quality and regulatory training modules and sessions for employees and stakeholders
- Complete all mandatory company training and job-specific training required for the role, including Information Security Management System (ISMS), DocuSign, SDLC and GDPR/HIPAA awareness, as applicable
- Occasional international travel (approx. 10%) may be required to support regulatory or customer audits
About You (Skills and Experience):
Essential
- 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
- Excellent communication, collaboration and stakeholder management skills, including technical report writing
- Strong analytical and problem-solving skills, with the ability to work independently and manage multiple priorities and deadlines
Desirable
- 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
