Job Description

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.

Requirements added by the job poster

• Bachelor’s Degree