limbic - Compliance and Regulatory Associate

• Information Security & Data Protection • Support the maintenance of our ISO 27001 ISMS by updating policies, procedures, and control evidence, and helping prepare for internal and external audits. • Assist with data protection administration: maintaining records of processing activities, supporting data subject access requests, and tracking compliance obligations under UK GDPR and relevant US frameworks including HIPAA. • Coordinate security testing activity, working with the InfoSec Lead to scope, schedule, and track penetration testing and vulnerability assessments, and following up on remediation actions. • Support supplier and vendor management: processing third-party security assessments, maintaining the vendor risk register, and chasing outstanding responses. • Manage security-related onboarding and offboarding processes, including access control reviews and checklist completion. • Maintain the security incident register, support initial triage and documentation of incidents, and track CAPAs through to closure. • Prepare responses to customer security questionnaires and assurance requests for external partners • Own the administrative chasing layer: tracking outstanding sign-offs, forms, training acknowledgements, and evidence requests across the business. • Regulatory Affairs & Quality • Support QMS documentation under ISO 13485 by maintaining and updating SOPs, work instructions, and quality records, and assisting with audit evidence preparation. • Assist with complaint and CAPA tracking: logging complaints and adverse events, monitoring closure timelines, and supporting documentation of corrective and preventive actions. • Support change control administration: preparing and tracking change request documentation across product and process changes. • Assist with regulatory filing and technical file maintenance for UK and US medical device requirements, including UK MDR 2002 and FDA SaMD guidance. • Provide documentation support for new product introductions. • Support QMS supplier qualification processes and documentation. • Cross-Functional & Operational • Help coordinate and track evidence for ISO 27001 and ISO 13485 internal and external audits, including liaising with Engineering, Product, and Operations teams. • Support the wider company's transition into compliant operations by helping communicate new processes, coordinate training, and embed controls across functions. • Assist with identifying opportunities to reduce manual overhead through process improvement and workflow automation, as capacity allows.