Project Manager – IVD Development

We are seeking an experienced and delivery-driven Project Manager to lead the integrated development of an innovative in vitro diagnostic (IVD) medical device from early-stage concept through to regulated market readiness.

In this pivotal role, you will provide structured leadership across engineering, regulatory, and clinical workstreams, ensuring clarity of direction, disciplined execution, and transparent reporting in a dynamic start-up environment. You will work in close partnership with internal teams and external collaborators, maintaining clear visibility of progress, risks, dependencies, and critical decision points for senior leadership.

Key Responsibilities

• Lead and maintain integrated, cross-functional project plans spanning software, hardware, regulatory, and clinical development

• Drive coordinated execution across internal teams and external partners to ensure alignment on scope, timelines, and deliverables

• Guide the transition from prototype to regulated medical device, ensuring compliance with ISO 13485 and the ISO 18113 series

• Proactively identify risks, manage dependencies, and facilitate informed trade-off decisions

• Structure and lead technical design reviews, project retrospectives, and cross-functional communication forums

• Facilitate robust requirements definition, change control, and decision-making processes

• Translate evolving product and regulatory requirements into clear milestones, prioritised backlogs, and achievable delivery plans

• Champion disciplined documentation, traceability, and scalable ways of working appropriate to a growing organisation

• Contribute to the implementation, maintenance, and continuous improvement of the Quality Management System (QMS)

About You

You are a proactive, solutions-oriented Project Manager with demonstrated experience delivering medical devices or IVDs through the full product development lifecycle. You are comfortable operating in environments where requirements evolve and ambiguity exists, and you bring the structure and clarity needed to enable technical teams to perform at their best.

You combine strong organisational and stakeholder management skills with a solid understanding of hardware and/or software development lifecycles within a regulated setting. You thrive in small, collaborative teams and are confident working with external partners, suppliers, and regulatory stakeholders.

Desirable:

• Direct experience in full lifecycle IVD development

• Working knowledge of ISO 13485 and the ISO 18113 series