Medical Device Development
Location: UK (Office-based, full-time permanent)
Salary: Competitive + Equity + Benefits (commensurate with experience)
About the Opportunity
They are a high-growth, venture-backed UK medical device company developing a novel, next-generation medtech platform designed to address critical unmet clinical needs.
Following successful clinical trials and with active US studies underway, they are preparing for our 510(k) regulatory submission and gearing up for commercial launch. To maintain this momentum, they are seeking an experienced, hands-on Project Manager to take ownership of thier core product development programme.
This is a high-visibility, cross-functional role at the heart of our operations. Working directly with executive leadership, you will serve as the operational heartbeat of our engineering, clinical,regulatory, and supply chain work streams.
Key Responsibilities
Programme & Execution Management
• Own and maintain the Integrated Development Plan (IDP) across hardware, software, and system-level work streams.
• Translate high-level milestones into detailed work plans, critical path analyses, and resourcing strategies.
• Proactively manage risks, drive resolutions, and deliver status reporting directly to executive leadership.
• Maintain and manage the Design History File (DHF) timeline to support the planned regulatory pathway.
Cross-Functional Leadership
• Act as the central coordination point across engineering, clinical affairs, regulatory, quality, and supply chain teams.
• Manage third-party development partners and contract suppliers, holding vendors accountable to timelines and deliverables.
Coordinate logistics for bench testing, pre-clinical work, and international clinical study site readiness.
Regulatory & Quality Compliance
• Ensure all development activities align with ISO 13485, FDA (510k), and MDR design control requirements.
Structure project activities to generate robust design verification and validation (V&V) evidence.
Support document control, design reviews, and formal phase-gate processes.
Budget & Financial Oversight
• Own and track the development programme budget, maintaining detailed cost forecasts across all workstreams.
• Validate cost inputs from external suppliers, CROs, and internal teams to ensure accurate financial reporting.
Assist in onboarding scale-up contract manufacturers and service providers as the company transitions to commercialisation.
Person Specification
Essential
Education: Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
Experience: 5+ years of project management experience within medical device development.
Track Record: Proven history of driving Class II/III medical devices through to regulatory submission.
Regulatory Knowledge: Strong working knowledge of ISO 13485, design controls, and FDA 510(k) / CE-mark pathways.
Tool Proficiency: Mastery of planning tools such as MS Project, Smartsheet, Jira, or equivalent
Mindset: Highly organized self-starter who thrives in a lean, fast-paced, startup environment.
Presence: Excellent communication skills, with the ability to sit office-based in the UK with periodic international travel.
Desirable
Direct experience managing US FDA regulatory interactions or GLP/GMP study programmes.
Formal PM qualifications (PMP, PRINCE2, APM).
Prior experience in a early-stage, venture-backed medical device startup.
What they Offer
High Impact: A pivotal role with direct access to executive leadership and a seat at the core development table.
Competitive Package: Excellent salary, meaningful equity participation, and comprehensive benefits.
Growth Opportunity: The chance to shape both a ground-breaking product and the organisation as it scales globally.
Collaborative Culture: A dynamic, hands-on team environment where your work directly impacts patient outcomes
Salary description
£80000.00 - £90000.00 per year