Chief Operating Officer (COO)

Regulatory, Quality, Manufacturing & Operational Delivery

Reports to: Chief Executive Officer

Role Purpose

ScubaTx is entering a delivery critical execution phase, spanning ISO 13485 certification, FDA 510(k) preparation, verification and validation (V&V), supply chain establishment, and manufacturing readiness for US launch.

We are appointing a Chief Operating Officer (COO) to act as the single named execution owner across operational delivery, quality, regulatory readiness, manufacturing, and supply chain. This role exists to convert strategy and plans into evidence, artefacts, and predictable execution, enabling the CEO and CSO to focus on strategy, fundraising, and scientific leadership.

This is not a coordination or PMO role. The COO holds real authority, is accountable for delivery outcomes, and is expected to actively manage plans, respond to real world constraints, and propose corrective actions to the Senior Management Team (SMT).

The COO is Accountable and Responsible (A/R) for industry standard MedTech execution ownership, including:

ISO 13485 Quality Management System (QMS) implementation, maintenance, and audit readiness

Design History File (DHF) integrity, traceability, and audit defensibility

Verification & Validation (V&V) strategy, planning, and execution

Design controls, risk management (ISO 14971), and associated regulatory artefacts

Manufacturing and supply chain readiness through early scale up

Integration of regulatory, manufacturing, and commercial timelines into a single delivery plan

Operational delivery cadence with clear, board ready reporting

Execution ownership is internal, explicit, and non delegable, even where specialist activities are delivered by consultants or suppliers.

Key Responsibilities

Quality, Regulatory & Compliance Execution

Own end to end delivery of the ISO 13485 QMS, from definition through certification and maintenance

Maintain continuous audit readiness across documentation, processes, and behaviours

Own DHF completeness, design control alignment, and traceability

Own V&V strategy, schedules, dependencies, and evidence generation

Act as senior internal owner of FDA 21 CFR 820 aligned operational readiness

Lead, manage, and challenge external QA/RA consultants against defined scope, milestones, and outputs

Manufacturing & Supply Chain Readiness

Define manufacturing and supply chain strategy from first principles (UK vs US vs ROW; in house vs outsourced)

Lead supplier identification, qualification, and onboarding

Negotiate and manage supplier contracts from an operational, quality, and delivery perspective, in alignment with CFO owned commercial terms, payment structures, and cash constraints

Establish supplier quality agreements and incoming inspection strategies

Ensure manufacturing and supply chain readiness is aligned with regulatory submissions and US launch plans

Integrated Delivery & Complex Programme Management

Build, own, and continuously manage the integrated operational delivery plan across:

Quality & regulatory milestones

V&V execution

Supply chain and manufacturing readiness

Actively manage delivery in response to real world challenges, constraints, or failures

Proactively surface delivery risks, trade offs, and mitigation options to the SMT

Drive corrective actions and reset plans where required to protect outcomes

Partner with the CFO to assess delivery risks with material cash, cost, or runway implications, ensuring timely escalation and coordinated recommendations to the SMT and Board

Operational Governance & Cadence

Establish and own a clear operational execution cadence

Produce board ready operational updates, dashboards, and evidence packs

Ensure decisions are presented with clear options, implications, and recommendations

Maintain alignment between the integrated delivery plan and the CFO owned financial plan, ensuring a single, consistent view of timelines, risks, and trade offs at board level

Executive Leadership & Continuity

Maintain operational momentum, decision clarity, and team confidence

Represent ScubaTx with auditors, suppliers, partners, and investors as required

Champion disciplined execution culture across the organisation

Oversight Interfaces

CEO: Strategic direction, escalation, and resource prioritisation

CSO: Scientific and clinical risk input (consulted)

Technical Director: Engineering design authority and change control (consulted)

CFO: Cash stewardship, supplier payment governance, capital and cost discipline (aligned)

The COO owns operational execution and delivery outcomes.

Experience & Profile

Senior operational leadership experience in regulated medical device environments

Proven ownership of complex, cross functional delivery programmes

Demonstrated delivery of ISO 13485 QMS implementation and audit readiness

Hands on experience with DHF, V&V, design controls, and risk management

Manufacturing and supply chain establishment and supplier qualification experience

Strong complex programme / delivery management capability

Comfortable operating autonomously with executive authority and accountability

Startup or scale up MedTech background

Prior COO, Head of Operations, or equivalent senior execution role

Stage Expectations

This is a hands on COO role during a delivery critical phase, requiring active management of plans, people, and problems. The role is expected to evolve as ScubaTx progresses from regulatory readiness into early commercial execution and scale.

Salary Expectation

Competitive salary, depending on experience, plus participation in the company's equity incentive scheme.

ScubaTx's success over the next phase depends on disciplined execution under regulatory, manufacturing, and supply chain constraints. The COO will be the executive who ensures that what is promised is built, evidenced, and ready on time.