Quality Assurance Specialist

QA/RA Specialist, Clinical, North AmericaLocation: Naperville, Illinois — hybrid role, 2/3 days per week on siteType: Full-time, permanentAbout this RoleWe 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 AssuranceImplement 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 operationsOwn 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 standardsManage quality processes including planned deviations, non-conformances, corrective and preventive actions (CAPAs), change management and maintenance of the risk registerIncident 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 CLIACoordinating 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 processesSupport client audits of clinical processes and coordinate post-audit activities, working closely with client quality teams on training, audit coordination and client evaluation documentsProvide routine quality metrics to management for KPI monitoring and trend analysisSupport the laboratory safety programmeDrive 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 HIPAARegulatory AffairsWork 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 technologiesCompile and review technical documentation required for regulatory submissions for Diagnexia clinical digital pathology solutions in the US and CanadaMake 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 activitiesCoordinate post-market surveillance (PMS) activities for clinical products and services, and write and submit periodic regulatory reports to authorities as requiredMonitor 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 complianceMaintenance of regulatory intranetEnsure compliance with applicable privacy and information security requirements, including HIPAA and GDPREstablish, 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 reviewsReview new marketing materials and change requests where these may impact regulatory or customer filingsGeneralParticipate in clinical and laboratory leadership meetings and provide quality and regulatory inputsFoster a culture of quality and compliance within clinical operationsDeliver quality and regulatory training modules and sessions for employees and stakeholdersComplete 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 applicableOccasional international travel (approx. 10%) may be required to support regulatory or customer auditsAbout You (Skills and Experience):EssentialBachelor's degree or higher in Life Sciences, Clinical Laboratory Science, Computer Science or a related fieldAt least 5 years' experience in a quality assurance and/or regulatory affairs role within a regulated life science, clinical services or medical device environmentStrong knowledge of US laboratory regulations, including CLIA 42 CFR 493 and CAP General Laboratory, Anatomic Pathology and proficiency testing requirementsWorking knowledge of FDA regulations applicable to clinical digital pathology, including 21 CFR 820Excellent communication, collaboration and stakeholder management skills, including technical report writingStrong analytical and problem-solving skills, with the ability to work independently and manage multiple priorities and deadlinesDesirableExperience managing a CAP laboratory accreditation programme, or certification/professional training in CLIA/CAP laboratory accreditation or regulatory affairsExperience with Software as a Medical Device (SaMD) and medical device regulationExperience with US and Canadian regulatory frameworks for SaaS products and clinical servicesExperience with digital pathology scanning equipment and software systems, AI technologies and emerging AI standards, and/or pathologist licensing and credentialingExperience with laboratory billing practices, Stark Law, anti-kickback and anti-markup rulesExperience with recognised quality management systems or standards such as ISO 13485, ISO 15189:2022 or equivalentAbout the CompanyThrough 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.What are the benefits of working with Deciphex?Healthcare benefitsCompetitive annual leaveA true sense of meaning in your work by contributing to better patient outcomes.The opportunity to work alongside a world-class high performing team in a hyper-growth startup environment.A chance to work on exciting, challenging and unique projects.Regular performance feedback and significant career growth opportunities.A highly collaborative and supportive multi cultural team.Deciphex is an equal opportunities employer and we are committed to the principle of equality. All qualified applicants will be considered for employment without regard to age, race, religious beliefs, political views, gender identity, affectional or sexual orientation, national origin, family or marital status (including pregnancy), disability, membership of the travelling community or any other classification protected by applicable law.A copy of our Privacy Policy can be viewed here