QA RA Specialist

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

About the Company

Through the work that we do, the team at Deciphex helps pharma to accelerate the process of essential drug development and helps patients to get timely and accurate diagnosis.

Founded in Dublin in 2017, Deciphex has scaled rapidly to a team of over 230 people and counting who are providing software solutions to address the pathology gap in research pathology and clinical areas. We have offices in Dublin, Exeter, Oxford, Toronto and Chicago and are expanding our team throughout the world.

We are software developers, clinical specialists, AI engineers, operations professionals and so much more, all working as one team to support our customers and patients. Our team culture is built on trust. We give our team the space they need to deliver results and the environment to ensure they can enjoy doing it.

We are looking for highly motivated individuals who are excited to take on challenges and value making a difference in their day-to-day work. This is a unique opportunity to make a difference in the emerging Digital Pathology field.

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