ScubaTx Limited
Manchester, Lancashire
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.
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.
ScubaTx Limited
Manchester, Lancashire
Location: Manchester, UK (Manchester Science Park) - with frequent travel (including to Houston, Texas, USA) Reports to: Chief Scientific Officer (Project Director), with day-to-day technical liaison to the Technical Director Contract: Permanent, full-time Start date: September 2026, or by negotiation to accommodate PhD completion Salary: Dependent on experience Funding: Year 1 funded through the Innovate UK Biomedical Catalyst Post-Accelerator grant (ATC-Heart project); ScubaTx intends this to be an ongoing, permanent role supporting continued US commercial deployment beyond the grant period Role Purpose ScubaTx's Active Temperature Control (ATC-Heart) platform is moving from laboratory-validated device into real-world deployment with an Organ Procurement Organisation (OPO) and clinical partners in Houston, Texas. The Medical Liaison Scientist (MLS) will be ScubaTx's dedicated, on-the-ground representative for this deployment: coordinating day-to-day activity with LifeGift and Houston-based clinicians, translating technical and clinical performance into commercial value, and ensuring the system integrates smoothly into existing OPO and transplant workflows. This is a new, dedicated role rather than an extension of an existing one. The project requires sustained, continuous on-the-ground presence in Houston throughout the real-world deployment phase - a level of engagement that cannot be provided alongside the existing part-time, ad hoc or strategic-oversight commitments of the CEO, CSO and Technical Director. Key Responsibilities 1. Real-world deployment support Coordinate day-to-day logistics of ATC-Heart deployment with LifeGift (Houston OPO) and Texas-based clinical partners (Texas Heart Institute, Texas A&M/EnMed). Provide on-site training and workflow-integration support for OPO recovery teams and transplant clinicians, working with the Technical Director on device troubleshooting where required. Monitor, record and quality-check device performance, reliability and usability data generated during real-world transport and preservation. Support ScubaTx's relationships with OPO staff, transplant surgeons and coordinators, serving as an accessible and professional day-to-day contact throughout the project. Build and maintain relationships with Houston-based clinicians and OPO leadership, representing ScubaTx professionally at customer sites. Maintain a clear feedback loop between the field and the UK technical and commercial teams. 3. Data analysis & customer value modelling Support structured customer insight gathering (workflow requirements, adoption criteria, procurement decision drivers). Analyse real-world performance and usability data generated during deployment. Contribute data collection and analysis in support of the quantified customer value model, working under the direction of the Project Director. 4. Reporting, training & dissemination Produce regular field reports and contribute to milestone and stage-gate reporting to the Project Director. Support development of customer-facing training materials and clinician communication resources. Contribute to conference presentations and publications of project findings (e.g. ISHLT, AOPO), subject to commercial confidentiality. Prepare and maintain product materials for clinical interactions, including leaflets, slide decks and other resources to support customer-facing activities. Support the design and execution of further evidence-generating initiatives as identified by the Project Director. Assist in drafting and reviewing publications and scientific communications in collaboration with clinicians and academic scientists. Travel Requirements This role is based in ScubaTx's Manchester office but requires frequent travel to Houston, Texas, concentrated during the real-world deployment phase of the project (approximately November 2026 - June 2027): During the deployment phase: on-the-ground presence in Houston of approximately one week in every four to six weeks, with more frequent trips around key training and deployment milestones. Before and after this window: shorter, more occasional visits for relationship-building, planning and follow-up. Occasional additional travel to other US sites or relevant conferences as required. Candidates must be able to travel to, and undertake business activity in, the United States (e.g. via ESTA/B-1 or equivalent business travel authorisation). Person Specification Degree (BSc, MSc, or PhD, including candidates in the final stages of thesis completion) in a relevant life sciences, biomedical engineering, clinical or related discipline. Experience in a clinical, medical device or life-sciences commercial environment, ideally involving direct interaction with clinicians, hospital or procurement staff. Relevant doctoral research experience in a life sciences or clinical context will be considered equivalent. Strong data analysis skills (e.g. Excel and/or statistical software), with the ability to translate technical and clinical data into clear commercial insight. Excellent written and verbal communication skills, comfortable liaising confidently with senior clinicians and OPO leadership. Willingness and ability to travel frequently and independently to the USA, as set out above. Self-motivated and comfortable operating with significant autonomy while based remotely from the core UK team. Familiarity with organ transplantation, organ preservation, or OPO operations. Experience with medical device field deployment, clinical evaluations, or post-market surveillance. Understanding of US healthcare and transplant procurement/reimbursement pathways. Prior experience supporting an early-stage or scale-up medtech company. About ScubaTx ScubaTx is a Manchester- and Houston-based medical device company developing the Active Temperature Control (ATC) platform: a reusable, plug-and-play system that actively regulates and maintains precise, tuneable temperatures for donor organs during transport, alongside proprietary oxygen persufflation technology. ATC-Heart, the company's first product application, is approaching FDA 510(k) submission and initial US commercial deployment. This role is central to that transition from late-stage development into real-world clinical use.
Location: Manchester, UK (Manchester Science Park) - with frequent travel (including to Houston, Texas, USA) Reports to: Chief Scientific Officer (Project Director), with day-to-day technical liaison to the Technical Director Contract: Permanent, full-time Start date: September 2026, or by negotiation to accommodate PhD completion Salary: Dependent on experience Funding: Year 1 funded through the Innovate UK Biomedical Catalyst Post-Accelerator grant (ATC-Heart project); ScubaTx intends this to be an ongoing, permanent role supporting continued US commercial deployment beyond the grant period Role Purpose ScubaTx's Active Temperature Control (ATC-Heart) platform is moving from laboratory-validated device into real-world deployment with an Organ Procurement Organisation (OPO) and clinical partners in Houston, Texas. The Medical Liaison Scientist (MLS) will be ScubaTx's dedicated, on-the-ground representative for this deployment: coordinating day-to-day activity with LifeGift and Houston-based clinicians, translating technical and clinical performance into commercial value, and ensuring the system integrates smoothly into existing OPO and transplant workflows. This is a new, dedicated role rather than an extension of an existing one. The project requires sustained, continuous on-the-ground presence in Houston throughout the real-world deployment phase - a level of engagement that cannot be provided alongside the existing part-time, ad hoc or strategic-oversight commitments of the CEO, CSO and Technical Director. Key Responsibilities 1. Real-world deployment support Coordinate day-to-day logistics of ATC-Heart deployment with LifeGift (Houston OPO) and Texas-based clinical partners (Texas Heart Institute, Texas A&M/EnMed). Provide on-site training and workflow-integration support for OPO recovery teams and transplant clinicians, working with the Technical Director on device troubleshooting where required. Monitor, record and quality-check device performance, reliability and usability data generated during real-world transport and preservation. Support ScubaTx's relationships with OPO staff, transplant surgeons and coordinators, serving as an accessible and professional day-to-day contact throughout the project. Build and maintain relationships with Houston-based clinicians and OPO leadership, representing ScubaTx professionally at customer sites. Maintain a clear feedback loop between the field and the UK technical and commercial teams. 3. Data analysis & customer value modelling Support structured customer insight gathering (workflow requirements, adoption criteria, procurement decision drivers). Analyse real-world performance and usability data generated during deployment. Contribute data collection and analysis in support of the quantified customer value model, working under the direction of the Project Director. 4. Reporting, training & dissemination Produce regular field reports and contribute to milestone and stage-gate reporting to the Project Director. Support development of customer-facing training materials and clinician communication resources. Contribute to conference presentations and publications of project findings (e.g. ISHLT, AOPO), subject to commercial confidentiality. Prepare and maintain product materials for clinical interactions, including leaflets, slide decks and other resources to support customer-facing activities. Support the design and execution of further evidence-generating initiatives as identified by the Project Director. Assist in drafting and reviewing publications and scientific communications in collaboration with clinicians and academic scientists. Travel Requirements This role is based in ScubaTx's Manchester office but requires frequent travel to Houston, Texas, concentrated during the real-world deployment phase of the project (approximately November 2026 - June 2027): During the deployment phase: on-the-ground presence in Houston of approximately one week in every four to six weeks, with more frequent trips around key training and deployment milestones. Before and after this window: shorter, more occasional visits for relationship-building, planning and follow-up. Occasional additional travel to other US sites or relevant conferences as required. Candidates must be able to travel to, and undertake business activity in, the United States (e.g. via ESTA/B-1 or equivalent business travel authorisation). Person Specification Degree (BSc, MSc, or PhD, including candidates in the final stages of thesis completion) in a relevant life sciences, biomedical engineering, clinical or related discipline. Experience in a clinical, medical device or life-sciences commercial environment, ideally involving direct interaction with clinicians, hospital or procurement staff. Relevant doctoral research experience in a life sciences or clinical context will be considered equivalent. Strong data analysis skills (e.g. Excel and/or statistical software), with the ability to translate technical and clinical data into clear commercial insight. Excellent written and verbal communication skills, comfortable liaising confidently with senior clinicians and OPO leadership. Willingness and ability to travel frequently and independently to the USA, as set out above. Self-motivated and comfortable operating with significant autonomy while based remotely from the core UK team. Familiarity with organ transplantation, organ preservation, or OPO operations. Experience with medical device field deployment, clinical evaluations, or post-market surveillance. Understanding of US healthcare and transplant procurement/reimbursement pathways. Prior experience supporting an early-stage or scale-up medtech company. About ScubaTx ScubaTx is a Manchester- and Houston-based medical device company developing the Active Temperature Control (ATC) platform: a reusable, plug-and-play system that actively regulates and maintains precise, tuneable temperatures for donor organs during transport, alongside proprietary oxygen persufflation technology. ATC-Heart, the company's first product application, is approaching FDA 510(k) submission and initial US commercial deployment. This role is central to that transition from late-stage development into real-world clinical use.