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
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Medical Device Programme Lead in London employer: Barrington James
Barrington James is an exceptional employer that fosters a collaborative and innovative work culture, making it an ideal place for professionals in Epidemiology and Real-World Evidence. With a strong emphasis on employee growth, we offer tailored development opportunities and the chance to lead impactful projects across diverse therapeutic areas in the dynamic UK/Europe market. Join us to be part of a team that values flexibility, creativity, and meaningful contributions to healthcare advancements.
