Medical Device Programme Lead - Infusion Platform (Hybrid)

Cpl Life Sciences; Greater London; Hybrid; GBP 120,000 - 170,000; Full time

Benefits offered by this job

Hybrid/Remote UK-based

Exposure to senior leadership

Job summary

CPL Life Sciences is seeking a Medical Device Programme Lead to own a late-stage drug-device combination programme. You will drive cross-functional delivery across Clinical, Regulatory, Quality and Manufacturing, coordinating external partners to meet safety, efficacy and regulatory milestones.

You will shape strategy, governance and risk management, oversee design controls, software elements, and supply planning, and ensure robust evidence generation for global submissions.

Qualifications

• Proven experience delivering medical device programmes within biotech/medtech or sponsor organisations.
• 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.
• Experience with Software as a Medical Device (SaMD) and IEC 62304.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.

Skills

Programme leadership

External partner management

Regulatory knowledge

SaMD/IEC 62304 understanding

Education

Engineering or Life Sciences degree

Tools

ISO 13485

ISO 14971

IEC 62304

Job description

CPL Life Sciences is seeking a Medical Device Programme Lead to own a late-stage drug-device combination programme. You will drive cross-functional delivery across Clinical, Regulatory, Quality and Manufacturing, coordinating external partners to meet safety, efficacy and regulatory milestones.

You will shape strategy, governance and risk management, oversee design controls, software elements, and supply planning, and ensure robust evidence generation for global submissions.