Islacare is a healthcare SaaS company building digital tools for remote care delivery. Its platform helps healthcare providers manage clinical pathways end to end, capture patient information in real time, and support decisions across a range of medical specialties. Designed for multidisciplinary collaboration, the specialty-agnostic system enables secure communication between patients and clinicians while fitting existing workflows without additional hardware or complex installations. By bringing clinical data, coordination, and pathway management into one configurable platform, Islacare aims to help care teams reduce administrative work, shorten waiting times, and improve operational efficiency and patient outcomes.
Compliance and Regulatory Manager – Digital Health (SaMD), London Hybrid
Lead quality management, SaMD regulation, GDPR, clinical safety and information security compliance for a UK digital health business. Drive audit readiness, certification programmes and regulatory assurance across healthcare technology operations.
Description
- Own and embed the Quality Management System as Quality Management Officer
- Lead internal audits, CAPAs, non-conformances, change control, supplier monitoring and management reviews
- Advance medical device regulatory readiness and the roadmap toward Class IIa ambitions
- Coordinate device 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 completed and tracked
- Embed quality, security and compliance standards across software development, product releases, information security and operations
- Identify compliance gaps, train colleagues and challenge practices that do not meet requirements
- Lead Cyber Essentials and Cyber Essentials Plus certification, 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 suitable controls
- Manage business policies, insurance, supplier obligations and contractual compliance
- Interpret regulatory requirements across the UK, EU and other international markets
- Coordinate regulatory advisers, auditors and certification bodies, converting recommendations into actions
- Work across Engineering, Product, Delivery, Operations, external regulatory specialists and clinical specialists
Requirements
- Hands-on experience managing quality, regulatory and compliance programmes in healthtech or medical devices
- Practical experience with medical device classification, registration and ongoing compliance, ideally covering Software as a Medical Device (SaMD) and Class IIa requirements
- Experience implementing, maintaining and improving a Quality Management System
- Experience with ISO 9001 and, ideally, ISO 13485
- Strong working knowledge of UK and EU GDPR
- Practical experience managing data protection compliance across multiple jurisdictions
- Understanding of information security and governance requirements
- Experience coordinating assurance or certification programmes such as NHS DSPT, Cyber Essentials or ISO 27001
- Experience managing internal audits, corrective and preventive actions (CAPAs), document control, change management, risk assessments and continuous improvement
- Experience creating policies, procedures and controls and embedding them across an organisation
- Experience partnering with cross-functional teams, technical specialists, external advisers and senior stakeholders
- Experience interpreting international healthcare and medical device regulations, including UK MHRA requirements, EU MDR or equivalent frameworks such as those in Australia
- Experience serving as a Quality Management Officer (QMO) or owning a QMS in a regulated organisation
- Experience serving as a designated Data Protection Officer (DPO), ideally in healthtech or an organisation handling sensitive personal data
- Experience with regulatory submissions, technical documentation, post-market surveillance or medical device certification
- Experience coordinating penetration tests, security assessments or remediation programmes
- Experience in a healthtech startup or scale-up where compliance processes were built or substantially improved
Benefits
- Choose to work from home or from the office at 131 Finsbury Pavement, Moorgate
- EMI share options
- Flexible working hours
- Work abroad for up to 90 days each year
- 25 days of annual leave plus bank holidays
- Take your birthday and one additional significant day of your choice off
- Quarterly meal allowance of up to £75 for friends or family
- £50 monthly wellbeing allowance for gym or wellbeing activities, or private medical insurance
- Salary sacrifice pension
- Mintago access for retail discounts, financial coaching, childcare vouchers and a virtual GP
- Enhanced parental leave
- Quarterly team social events
- Annual learning budget
- Contribute to social impact through improved patient healthcare
- Meaningful ownership and growth opportunities in a well-funded, rapidly growing healthtech company