tortus - Compliance Manager
Upload My Resume
Drop here or click to browse · Tap to choose · PDF, DOCX, DOC, RTF, TXT
Requirements
• Experience in Class II medical device or SaMD compliance • Strong working knowledge of ISO 27001, 13485, and broader ISO frameworks • Experience owning or contributing to a QMS • Experience supporting audits and maintaining certifications • Comfortable operating in a fast-moving, product-led environment • Mindset & capability • You understand software or can quickly get there. You don’t need to have been an engineer, but you need to be able to work closely with them • You’ve worked in (or can operate within) a product/tech team in a regulated space • You take ownership; of systems, deadlines, and outcomes • You’re structured, but pragmatic • Clinical background or experience working closely with clinical teams • Experience as a CSO (or willingness to become one) • Exposure to AI or data-driven healthcare products • Familiarity with NHS requirements (e.g. DSPT, DTAC) • Compensation: Competitive base salary, plus commission and bonus with upside. Meaningful equity in an early-stage company with strong NHS traction. • Impact: Help scale a company with proven clinical outcomes from startup to NHS-wide deployment. Our data shows clinicians get 25% more patient-facing time. • Team: Join a small, growing Commercial team. You'll help define how we sell, not just execute a playbook. • Mission: Give clinicians back their time. This is life-changing for doctors and improves patient care at scale. • Location: London-based (Holborn) with three days per week in the office
Responsibilities
• OWN CLASS II MEDICAL DEVICE COMPLIANCE • Act as the internal lead for Class II regulatory requirements and standards • Own and evolve our Quality Management System (QMS) • Ensure our product remains compliant as it evolves (features, integrations, deployments) • Work closely with product and engineering to embed compliance into how we build • BE THE INTERNAL OWNER FOR ISO • Act as the point person for ISO 13485 and ISO 27001 • Maintain standards through internal audits, process updates, and continuous improvement • Ensure documentation, policies, and controls are audit-ready at all times • MANAGE AUDITS AND CERTIFICATION • Own preparation for audits and regulatory inspections • Coordinate evidence gathering and responses • Track and close CAPAs • Maintain UKCA and other relevant certifications • OWN EXTERNAL COMPLIANCE RELATIONSHIPS • Manage external partners across: • Cyber Essentials Plus • Ensure we meet all deliverables and deadlines without internalising unnecessary scope • Stay accountable for outcomes, even when execution is outsourced • CLINICAL SAFETY & GOVERNANCE • Likely act as (or grow into) a Clinical Safety Officer (CSO) • Support clinical risk processes (e.g. hazard workshops) • Act as a point of contact for clinical safety queries • OPERATE CROSS-FUNCTIONALLY • Work deeply with product and engineering teams • Translate regulatory requirements into practical decisions • Support customer and NHS-facing compliance processes (e.g. DTAC, DPIAs)
No credit card. Takes 10 seconds.