Medical Device Programme Lead

Barrington James; United Kingdom; Sur place; GBP 85 000 - 120 000; Plein temps

Résumé du poste

Barrington James is seeking an experienced programme leader to take full ownership of an infusion device programme, reporting to the Chief Solutions Officer. You will drive end-to-end activities from design control through to clinical or commercial use, coordinating external design and manufacturing partners and overseeing submissions for US/EU regulatory paths.

You will also own the software side, including SaMD lifecycle and cybersecurity, ensuring tight design history files and traceability

Qualifications

• Infusion, injection or fluid delivery device development from design control to clinical or commercial use.
• Experience working with external design and manufacturing partners.
• Strong knowledge of ISO 13485, ISO 14971 and US/EU combination product requirements.

Responsabilités

• Own end-to-end device programme: plan, budget, risk, decisions.
• Hold design and manufacturing partners to scope; challenge testing and documentation.
• Maintain design history file and traceability.
• Deliver device content for US and EU submissions.
• Coordinate devices, kits and training materials to trial sites on schedule.
• Own the SaMD lifecycle and cybersecurity.

Connaissances

Device development

External partner mgmt

ISO 13485

ISO 14971

Combination products

Clinical trials supply

SaMD lifecycle

Cybersecurity

Lean startup experience

Description du poste

I'm working with a small, ambitious sponsor company with a late-stage drug-device combination programme. They need someone to take full ownership of the infusion device, reporting straight to the Chief Solutions Officer.

Design and manufacturing sit with external partners. You're the one holding it all together and making the calls.

What you'll be doing:

• Owning the device programme end to end: plan, budget, risk and decisions
• Holding design and manufacturing partners to scope, and challenging their testing and documentation
• Keeping the design history file and traceability tight
• Delivering device content for US and EU combination product submissions
• Getting verified devices, kits and training materials to trial sites on schedule
• Owning the software side, including SaMD lifecycle and cybersecurity

What you'll need:

• Infusion, injection or fluid delivery device development, through design control to clinical or commercial use
• Small-company experience: broad scope, lean support
• A track record managing external design and manufacturing partners
• Experience supplying devices into interventional clinical trials
• Strong ISO 13485, ISO 14971 and combination product knowledge (US and EU)
• Working knowledge of clinical and commercial builds

Nice to have: IEC 62304 / SaMD, AI-enabled devices, neurological or intraocular delivery, gene or cell therapy.

Regular travel to partner and clinical sites across Europe and the US.

#MedicalDevices #CombinationProducts #DrugDelivery #ProgrammeManagement #MedTechJobs