Compliance and Regulatory Manager – Digital Health, SaMD

Islacare

. Own and embed Isla Health’s Quality Management System as Quality Management Officer .

Posted 10/9/2026full-timeLondon • United KingdomMid-LevelSenior💰 £52,000 - £68,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Quality Management Systems, regulatory compliance, and data protection within the healthtech sector, with a strong focus on ISO standards and medical device regulations. Proven ability to lead audits, manage compliance activities, and collaborate with cross-functional teams to ensure adherence to quality and security standards.

Highest-signal resume keywords

Quality Management System ImplementationRegulatory Compliance ManagementISO 13485 ExperienceGDPR KnowledgeMedical Device Classification

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Quality Management SystemRegulatory ComplianceISO 13485ISO 9001CAPA ManagementRisk AssessmentDocument ControlChange ManagementTechnical DocumentationPost-Market Surveillance

Soft Skills

CollaborationLeadershipTrainingCommunicationProblem-Solving

Tools & Technologies

Cyber EssentialsNHS DSPTISO 27001Data Protection ToolsPenetration Testing Tools

Certifications & Qualifications

Cyber Essentials PlusData Protection Officer Certification

Industry Keywords

HealthtechMedical DevicesSaMDUK MHRAEU MDRInformation SecurityCompliance ManagementClinical SafetySupplier ManagementInternational Regulations

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

Hands-on experience in quality, regulatory and compliance management within healthtech or medical devices
Practical experience with medical device classification, registration and ongoing regulatory compliance, ideally involving 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 compliance activities, assurance or certifications 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 developing policies, procedures and controls and ensuring their adoption across an organisation
Experience working with cross-functional teams, technical specialists, external advisers and senior stakeholders
Experience navigating international healthcare and medical device regulations, including UK MHRA requirements, EU MDR or equivalent frameworks in markets such as Australia
Experience acting as a Quality Management Officer (QMO) or holding responsibility for a QMS in a regulated organisation
Experience acting as a designated Data Protection Officer (DPO), ideally within healthcare technology or an organisation handling sensitive personal data
Experience with regulatory submissions, technical documentation, post-market surveillance or medical device certification
Experience coordinating penetration testing, security assessments or remediation programmes
Experience working in a healthtech startup or scale-up where compliance processes were established or significantly improved

Benefits

Comp & perks

Work from home or the office in 131 Finsbury Pavement (Moorgate)
EMI share options
Flexible working times
Work abroad for up to 90 days per year
25 days annual leave plus bank holidays
Birthday off and another significant day off of your choice
Quarterly meal allowance of up to £75 for friends or family
Wellbeing allowance of £50 per month for gym membership/wellbeing activities or private medical insurance
Salary sacrifice pension
Access to Mintago for retail discounts, financial coaching, childcare vouchers and virtual GP
Enhanced parental leave
Quarterly team socials
Annual learning budget
Opportunity to deliver social impact through improved patient healthcare
Real ownership and opportunity for growth in a well-funded, rapidly growing health tech company