Medical Device Programme Lead

About the Opportunity

An innovative and fast-growing biotechnology company is seeking a Medical Device Programme Lead to take ownership of a critical drug-device combination product in late-stage development. This is a high-impact sponsor-side role overseeing the delivery of an infusion-based medical device platform that supports advanced therapeutic treatments.

Working cross-functionally with Clinical, Regulatory, Quality, Manufacturing, Procurement and Finance teams, you will lead external development and manufacturing partners to ensure the successful progression of the device through clinical and regulatory milestones.

This position offers significant visibility within the organisation and the opportunity to influence strategy, delivery, and decision-making across a complex combination product programme.

Key Responsibilities

Programme Leadership

• Own the medical device programme across all workstreams and external partners.
• Provide regular updates on programme status, risks, mitigation plans and key milestones.
• Maintain project plans aligned to clinical and regulatory timelines.
• Drive key development decisions including requirements management, design freeze readiness and scope governance.
• Manage programme budgets, purchase orders and financial reporting.

Partner & Vendor Management

• Lead and coordinate external development, manufacturing and specialist partners.
• Track contractual deliverables and proactively manage risks to delivery.
• Review technical documentation including protocols, reports and risk assessments.
• Challenge technical assumptions and ensure robust evidence generation.
• Oversee supply planning, component availability and clinical device manufacturing schedules.

Design Control & Regulatory Support

• Maintain oversight of design history documentation and development records.
• Ensure full traceability from user requirements through design verification and validation activities.
• Support global regulatory submissions for combination products.
• Collaborate with Quality and Regulatory teams to address agency questions and submissions.

Clinical Trial Support

• Ensure devices, kits, labelling and logistics are delivered to support clinical trial timelines.
• Coordinate training materials, instructions for use and technical support documentation.
• Manage device deficiencies, investigations and corrective actions in partnership with Quality and Safety teams.

Software & Digital Health

• Oversee software elements associated with the device platform.
• Ensure compliance with software lifecycle, cybersecurity and digital health requirements.
• Collaborate with technical and data science teams on future software-enabled functionality.

Required Experience

• Proven experience delivering medical device programmes within a biotech, medtech or small sponsor organisation.
• Strong background in infusion, injection or fluid delivery device development.
• Experience managing external design, manufacturing and testing partners.
• Knowledge of supporting devices within interventional clinical trials.
• Understanding of manufacturing operations, validation, supply planning and clinical builds.
• Strong knowledge of:
• ISO 13485
• ISO 14971
• Design Controls
• Combination Product Regulations (US and EU)
• Ability to independently lead programmes and make decisions within complex development environments.
• Degree in Engineering, Life Sciences, Computer Science, or a related discipline.

Desirable

• Experience with Software as a Medical Device (SaMD) and IEC 62304.
• Exposure to AI-enabled medical devices or clinical decision support technologies.
• Experience with neurosurgical, ophthalmic, intrathecal or targeted drug delivery systems.
• Background in gene therapy, cell therapy, or other advanced therapy medicinal products (ATMPs).

Why Apply?

• Join a highly innovative biotech developing transformative therapies.
• Lead a strategically important combination product programme.
• Work with cutting-edge device and digital health technologies.
• Flexible UK-based remote or hybrid working model.
• Significant exposure to senior leadership and cross-functional stakeholders.

To learn more or apply confidentially, please get in touch - jamie.keith@cpl.com