Islacare

Compliance

• Own and embed Isla Health’s Quality Management System as Quality Management Officer
• Lead internal audits, CAPAs, non-conformances, change control, supplier monitoring and management reviews
• Drive medical device regulatory readiness and the roadmap toward Class IIa ambitions
• Coordinate classification, registration, ISO 13485 readiness, technical documentation and post-market surveillance
• Coordinate clinical safety compliance with the Clinical Safety Officer, Product and Engineering teams
• Ensure clinical risk assessments, safety actions and incident reporting are followed through
• Embed quality, security and compliance standards across software development, product releases, information security and operations
• Identify compliance gaps, train colleagues and challenge non-compliant practices
• Drive Cyber Essentials and Cyber Essentials Plus certifications, penetration testing and security assurance
• Coordinate vulnerability remediation and security best practices with Engineering and other teams
• Lead information governance and data protection compliance across UK and international markets
• Manage GDPR, data retention, subject access requests, DPIAs, incident management and NHS information governance requirements
• Work with the designated DPO to identify risks and maintain appropriate controls
• Manage business policies, insurance, supplier obligations and contractual compliance
• Navigate regulatory requirements across the UK, EU and other international markets
• Coordinate regulatory advisers, auditors and certification bodies and turn recommendations into actions
• Collaborate with Engineering, Product, Delivery, Operations, external regulatory specialists and clinical specialists

Explore Compliance and Regulatory Manager – Digital Health, SaMD at Islacare. Review requirements and application details.