2 of 2 Contract ISO 13485 Jobs in London

Outside IR35, Uk wide, Quality Management, London, QMS, ISO 13485, Immediate Start, Agile, ISO 14971, AI, My leading client is looking for a strategic QMS Lead to build and embed an ISO 13485 -aligned Quality Management System for a cutting-edge healthcare platform. You'll drive compliance, shape governance, and prepare the business for audits … and accreditation-all while working closely with agile product teams. What You'll Do: Own the QMS strategy for SaMD. Lead ISO 13485 gap analysis and rollout. Embed QMS into agile workflows across product squads. Deliver training and drive adoption across tech teams. Liaise with auditors and regulators. Champion continuous improvement and quality culture. What You'll Bring … Deep ISO 13485 expertise in healthcare software. Proven track record from QMS design to accreditation. Strong grasp of Agile/DevOps in regulated environments. Confident communicator with top-tier documentation skills. Experience in pharma or MedTech platforms. Familiarity with ISO 14971, IEC 62304. Exposure to AI-enabled QMS tooling. If this role is of interest please send More ❯

QMS, SaMD, ISO 13485, IEC 62304, ISO14971, Medtech, Digital Healthcare, Software Development Lifecycle, Agile, Dev Ops My consultancy client is looking for a QMS lead with deep SaMD expertise to shape the future of digital healthcare services. You will lead the design, implementation, and continuous improvement of our ISO 13485-aligned QMS for our a cutting … as Software as a Medical Device (SaMD) . The key areas of expertise are to Own the QMS vision and strategy for the SaMD programme. Ensure full alignment with ISO 13485 , IEC 62304 , and ISO 14971 standards. Embed QMS principles into agile product squads without compromising delivery velocity - Strong understanding of software development life cycles (Agile, DevOps … in regulated environments. Prepare the organisation for external audits and ISO accreditation . Champion a culture of continuous improvement and quality-first thinking If this sounds of interest please send me your cv ASAP for review More ❯