Medical Device Programme Lead

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.

• 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

• 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.

#Medical Devices #Combination Products #Drug Delivery #Programme Management #Med Tech Jobs