Clinical Regulatory Specialist

Job Description Role Objective: The Clinical Regulatory Specialist is responsible for ensuring that PURA's AIenabled clinical tools comply with applicable regulations, standards and data privacy laws. The role maintains an ISO 13485-compliant Quality Management System, leads ISO 14971 risk management, supports regulatory submissions, and oversees audits, CAPA and post-market surveillance activities. It serves as a key link between regulatory bodies, clinical governance, product/engineering teams and data governance. Key Responsibilities: 1. Quality Management System (QMS) Ownership - Maintain, implement and continuously improve an ISO 13485-compliant Quality Management System tailored to PURA's SaMD and HITL workflows. - Ensure QMS processes are embedded into day-to-day operations with product, engineering, clinical and data teams. - Develop and maintain controlled documents, SOPs, work instructions and templates related to SaMD and AI-enabled clinical solutions. 2. Risk Management (ISO 14971) & HITL Integration - Lead ISO 14971 risk management activities across PURA's products, including hazard identification, risk analysis, evaluation and control. - Integrate HITL feedback and real-world performance data into risk assessments and periodic reviews. - Collaborate with clinical and technical teams to ensure risk control measures are implemented, verified and documented. 3. Regulatory Submissions & Design History File (DHF) - Prepare, coordinate and manage regulatory submissions for SaMD and AI-enabled tools, including FDA, EU MDR, and MOHAP UAE where applicable. - Own and maintain the Design History File (DHF), technical documentation and evidence related to clinical validation, performance and safety. - Ensure that documentation is complete, consistent and audit-ready across the full product lifecycle. 4. Standards Compliance (IEC 62304 & IEC 62366) - Enforce IEC 62304 software lifecycle processes in collaboration with software engineering and product teams. - Ensure usability engineering activities and evidence align with IEC 62366, particularly for HITL and clinician-facing workflows. - Provide guidance to teams on how to incorporate these standards into design, development and maintenance activities. 5. Audits, CAPA & Post-Market Surveillance - Plan, coordinate and host internal and external audits (regulators, notified bodies, internal assurance). - Manage the full CAPA lifecycle, ensuring timely investigation, root-cause analysis, corrective and preventive actions, and effective closure. - Operate post-market surveillance and vigilance reporting processes for PURA's SaMD and AI tools, including adverse event and incident reporting as required. 6. Data Governance, Privacy & Compliance - Ensure compliance with applicable data privacy and health data regulations (e.g., PDPL, Health Data Law and other relevant frameworks). - Work closely with Data Governance, Legal, IT Security and clinical teams to ensure safe, compliant use of clinical data in HITL workflows and AI model development. - Contribute to policies and processes governing data access, retention, anonymisation/pseudonymisation and cross-border transfers where relevant. 7. Release Governance & Clinical Boards - Run and document Go/No-Go release gates with the Clinical Governance Board and other stakeholders for new and updated PURA features. - Ensure all required regulatory, risk, QMS and data privacy criteria are met before deployment or scale-up. - Provide clear, evidence-based recommendations on release decisions from a regulatory and risk perspective. 8. Training, Awareness & Stakeholder Engagement - Provide training and guidance to cross-functional teams on regulatory requirements, QMS processes, documentation standards and audit readiness. - Act as a subject matter expert on SaMD, clinical AI regulation and relevant standards within the PURA and PureHealth ecosystem. - Build strong relationships with clinical leaders, product owners, engineers and data teams to embed a culture of quality and compliance. Qualification Requirements: - Bachelor's degree in a relevant field (e.g., Biomedical Engineering, Pharmacy, Life Sciences, Nursing, Quality/Regulatory discipline). - Significant experience in regulatory affairs, quality management or clinical compliance within medical devices, SaMD or healthcare technology environments. Skills & Competencies Regulatory & Standards Expertise - Expertise in SaMD regulations and frameworks (e.g., FDA, EU MDR, MOHAP UAE). - Strong working knowledge of ISO 13485, ISO 14971, IEC 62304 and IEC 62366. Audit, CAPA & Surveillance - Proven experience planning and managing internal and external audits. - Strong CAPA management skills, from investigation to closure. - Experience operating post-market surveillance and vigilance reporting processes. Clinical AI & Evidence Familiarity - Familiarity with clinical AI validation evidence, bias audits and performance monitoring approaches. Data Governance & Privacy - Strong understanding of healthcare data governance and privacy laws (e.g., PDPL, Health Data Law), and how they apply to AI validation and HITL workflows. Documentation & Communication - Excellent documentation discipline, attention to detail and record-keeping. - Strong written and verbal communication skills, with ability to work effectively with clinicians, engineers, product managers, auditors and regulators.