Commercialisation Acceleration Lead (CAL) – Regulatory Strategies Research Ireland ARC Hub for HealthTech

Summary of Post

The Research Ireland ARC Hub for HealthTech is a collaborative initiative between the University of Galway, Atlantic Technological University (ATU), and Royal College of Surgeons in Ireland, to guide academic projects in the MedTech and Connected Health sectors to commercial success on a national scale in conjunction with other Higher Education Institutions (HEI) in the Republic of Ireland. The ARC Hub, hosted by University of Galway, will support the translation of cutting-edge research into real-world applications and equip innovators with the knowledge and acumen needed to bring transformative healthcare technologies to market. The overall vision of the ARC Hub for HealthTech is to support Ireland's Smart Specialisation Strategy (S3) and drive growth in the Northern and Western Region by creating a world-class hub that translates MedTech and Connected Health innovations into effective chronic disease management solutions.

We are seeking a dynamic and experienced Commercialisation Acceleration Lead – Regulatory Strategies to provide expert advice to Translational Project teams, helping them navigate the challenges of bringing innovative health technologies to market. In particular, the Commercialisation Acceleration Lead (CAL) – Regulatory Strategies will provide expert advice and support in relation to the development of appropriate regulatory approval roadmaps and strategies. Working closely with CALs at other partner institutions and the RCSI Innovation Team, this is a dynamic and multifaceted role involves engaging with academic researchers in RCSI and other selected Irish third level institutions to identify suitable opportunities, working with these researchers to develop project submissions to the ARC, evaluating the commercial potential of novel healthtech innovations and developing investor-ready commercial and regulatory strategies for these technologies. As part of the wider ARC operations team, the RCSI-based CAL will also assist Translational Researchers (TRs) in developing robust business models, protecting intellectual property, crafting regulatory strategies, and defining pathways for market entry. Additionally, the CALs will serve as vital connectors—linking ARC Hub TRs with industry experts, potential customers, and strategic collaborators to accelerate the commercialisation journey. We seek an individual who has an excellent understanding of the medtech and connected health regulatory landscape and associated regulatory approval processes, who is goal-driven, proactive, meticulous and highly collaborative and whose goal is to take the next career step in a fast-moving, pioneering and dynamic environment. This role is pivotal in driving the success of the ARC Hub’s aim to advance research commercialisation of novel healthtech innovations in the ARC’s partner institutions. We’re looking for someone that is purpose-driven and feels passionate about supporting early stage and emerging Medtech and Connected Health start-ups that can have a positive impact on transforming the lives of patients through the development of innovative therapies. Specifically, the duties of the post are :

• Work with the ARC’s academic teams, other members of the ARC’s Operations team and the ARC’s Advisory Board to develop robust regulatory approval strategies for ARC funded projects with appropriate go / no-go milestones
• Liaise with the academic research community to identify and evaluate promising medtech and connected health projects, which may be invited to apply for future funding calls by the ARC.
• Work with the academic teams, the wider ARC Operations and Executive team and the ARC’s Advisory Board to develop robust commercialisation plans and go-to-market strategies and development plans for each funded project with appropriate go / no-go milestones.
• Support the Hub team to coordinate national funding calls for new projects, assist in application submission, pipeline review / triage, and post award grant management.
• Support the day-to-day operations of the ARC programme at RCSI including project managing a portfolio of translational research projects and troubleshooting operational issues as they arise.
• Track progress of projects against the agreed development plan and key deliverables to ensure each project meets quality standards and is delivered on time and within budget to support the ARC’s key performance indicator (KPI) metrics.
• Proactively manage project risks and facilitate problem-solving, contingency planning, and decision-making to resolve problems and minimize delays.
• Prepare and present regular project updates to ARC Senior management and Governance / Advisory Committees.
• Liaise with the Business Development and Training Manager to support the Translational Project teams to access the ARC Hub cohort of mentors, advisors, and Hub training resources. Qualifications – (Essential) :
• PhD or equivalent in life sciences or relevant discipline. Knowledge & Experience – (Essential) :
• Knowledge of the regulatory requirements (e.g., EU MDR, CE marking, FDA approval) associated with the commercialisation of novel medtech and connected health devices and the ability to assist teams in regulatory planning.
• Minimum of three years of experience in a new technology development role within the medtech and connected health field.
• Experience supporting the development of go-to-market strategies, including customer discovery and value proposition design.
• Demonstrated ability to facilitate connections with key stakeholders, including :
• Industry experts
• Strategic partners
• Potential customers
• Investors or funding bodies
• Proven experience in project or program management.
• Excellent scientific, organizational, communication and community-building skills.
• Ability to manage multiple projects and stakeholders effectively.
• Excellent written and oral communication skills.
• Proficiency in using Project Management tools, communication platforms and the Microsoft Office suite. Knowledge & Experience – (Desirable)
• Solid knowledge of intellectual property (IP) protection strategies, including patents, licensing, and freedom-to-operate analyses.
• Experience in guiding early-stage ventures or teams in the development of scalable and sustainable business models.
• Familiarity with tools such as the Business Model Canvas, Lean Startup methodology, or similar frameworks.
• Experience of managing or participating in medtech and connected health accelerator programme.
• Experience of academic spin-outs and the medtech start-up ecosystem in ireland. We are all too aware that imposter syndrome and the confidence gap can sometimes stop fantastic candidates putting themselves forward, so please do submit an application — we’d love to hear from you.