Medical Device Programme Lead

Barrington James; Greater London; Sur place; GBP 90 000 - 130 000; Plein temps

Résumé du poste

Barrington James is seeking a Medical Device Programme Lead for a late-stage drug-device combination programme in the UK. This hands-on, senior role requires ownership of timelines, risk decisions and end-to-end delivery, with close collaboration across clinical, regulatory, quality, manufacturing, procurement and finance teams.

You will review technical documentation, manage external design/manufacturing partners, and lead regulatory submissions while maintaining device quality and supply

Qualifications

• Experience leading medical device programmes within a sponsor, with broad ownership and limited internal support.

Responsabilités

• Own the medical device programme across timelines, risks, decisions and delivery.
• Manage external design and manufacturing partners, holding them accountable for deliverables.
• Review and challenge technical documentation, protocols, reports and risk analyses.
• Manage device development alongside clinical and regulatory timelines.
• Oversee builds, yields, component lead times, ordering and clinical supply.
• Own the device budget alongside Procurement and Finance.
• Support combination product submissions and regulatory responses.
• Ensure devices, kits, labelling and shipping are ready for clinical sites.

Connaissances

Programme leadership

Medical devices

Regulatory understanding

Vendor management

Clinical trials

Formation

Engineering degree

Life sciences degree

Outils

Design controls

Description du poste

I'm working with a specialist life sciences organisation that is looking to appoint a Medical Device Programme Lead to take ownership of a late stage drug device combination programme.

This is a hands-on programme leadership role with real responsibility.

You’ll work closely with clinical, regulatory, quality, manufacturing, procurement and finance teams and report directly to the Chief Solutions Officer.

What you'll be doing:

• Own the medical device programme across timelines, risks, decisions and delivery.
• Manage external design and manufacturing partners, holding them accountable for deliverables.
• Review and challenge technical documentation, protocols, reports and risk analyses.
• Manage device development alongside clinical and regulatory timelines.
• Oversee builds, yields, component lead times, ordering and clinical supply.
• Own the device budget alongside Procurement and Finance.
• Maintain oversight of the Design History File, design traceability and V&V.
• Support combination product submissions and regulatory responses.
• Ensure devices, kits, labelling and shipping are ready for clinical sites.
• Support IFUs, surgeon training and technical dosing requirements.
• Work with Quality and Pharmacovigilance on device deficiencies, investigations and CAPAs.
• Oversee software lifecycle and cybersecurity where relevant.

The experience they're looking for:

• Experience leading medical device programmes within a small sponsor, with broad ownership and limited internal support.
• Strong experience with infusion, injection or fluid-delivery devices from design control through clinical/commercial use.
• Proven experience managing external design and manufacturing partners.
• Experience supporting devices through interventional clinical trials.
• Understanding of manufacturing builds, lot planning, yield, lead times, tooling and process validation.
• Strong knowledge of ISO 13485, ISO 14971, design controls and combination product requirements across US/EU frameworks.
• Comfortable owning programmes where delivery is largely outsourced.
• Degree in engineering, computer science, life sciences or equivalent experience.

Nice to have:

• SaMD / IEC 62304
• Surgical planning, navigation or connected devices
• AI/model-enabled medical devices
• Neurosurgical or neurological delivery
• Stereotactic, intraparenchymal, intrathecal or intraocular delivery
• Gene, cell or other advanced therapy programmes