Chief Operating Officer (COO)

Written By David Campbell

Regulatory, Quality, Manufacturing & Operational Delivery

Location: Manchester (hybrid; UK‑based presence required)

Reports to: Chief Executive Officer

Scope: UK execution lead; senior delivery authority

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).

Core Accountability

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

  • Implement RAG‑based reporting with evidence‑backed status updates

  • 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

  • Act as senior UK‑based executive during CEO US travel

  • 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

Essential

  • 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

Desirable

  • FDA 510(k) submission preparation experience

  • 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.

To apply for this role email us at - info@scubatx.com. Please include COO in the subject.

David Campbell
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Quality & Regulatory Associate (Medical Devices)