MedTech COO: End-to-End Delivery & Quality Leadership

ScubaTx Limited; Manchester; On-site; GBP 150,000 - 210,000; Full time

Job summary

ScubaTx Limited is seeking a Chief Operating Officer to take sole ownership of execution across quality, regulatory readiness, manufacturing, and supply chain. The role requires delivering ISO 13485, FDA 510(k) preparation, V&V, and integrating timelines into a single delivery plan.

The COO leads with authority, partners with the SMT, and drives evidence-based results during a delivery‑critical phase. The position demands hands-on leadership, robust programme management, and the ability to align

Qualifications

• Senior operational leadership experience in regulated medical device environments
• Ownership of ISO 13485 QMS implementation and audit readiness
• Hands-on experience with Design History File (DHF) integrity and traceability
• Experience with Verification & Validation (V&V) strategy and execution
• Manufacturing and supply-chain establishment and supplier qualification
• Strong complex programme / delivery management capability

Responsibilities

• Own end-to-end delivery of ISO 13485 QMS and certification
• Maintain audit readiness across documentation and processes
• Own DHF completeness, design control alignment, and traceability
• Own V&V strategy, schedules, dependencies, and evidence
• Act as senior internal owner of FDA 21 CFR 820-aligned readiness
• Lead external QA/RA consultants against defined scope and milestones
• Define manufacturing and supply-chain strategy (UK vs US vs ROW)
• Lead supplier qualification and onboarding
• Negotiate supplier contracts from operational and delivery perspectives
• Establish supplier quality agreements and inspection strategies
• Ensure readiness aligns with regulatory submissions and US launch plans
• Build and manage integrated delivery plan across quality, V&V, supply chain
• Proactively surface delivery risks and mitigation options
• Drive corrective actions to protect outcomes
• Collaborate with CFO on delivery risks with cash/runway implications
• Produce board-ready operational updates and dashboards
• Maintain alignment with CFO-owned financial plan

Skills

Senior leadership

Delivery management

ISO 13485

QMS implementation

DHF management

V&V planning

Program governance

Job description

ScubaTx Limited is seeking a Chief Operating Officer to take sole ownership of execution across quality, regulatory readiness, manufacturing, and supply chain. The role requires delivering ISO 13485, FDA 510(k) preparation, V&V, and integrating timelines into a single delivery plan.

The COO leads with authority, partners with the SMT, and drives evidence-based results during a delivery‑critical phase. The position demands hands-on leadership, robust programme management, and the ability to align