Jonathan El-Sharkawy

Melbourne-based (no visa sponsorship required). Open on title for a permanent role in regulated healthtech/SaMD or other high-stakes software.

Swiss-army-knife leader across product, delivery, engineering and governance. Built an ISO 13485 QMS from scratch and kept it audit-ready for six years (0 major findings), embedding ISO 14971 / IEC 62304 into day-to-day delivery.

Shipped a UKCA-marked SaMD + drug combination device; removed ~£1m from scope and negotiated a 60% integration discount.

Completing ISO/IEC 42001 (working towards Lead Auditor). Founder background; named inventor on GB2104539.8.

Melbourne-based with full work rights (no sponsorship required). I sit at the “Swiss-army-knife” end of leadership in regulated healthtech (SaMD) and other high-stakes software: product, delivery, engineering and governance. I’m usually brought in when the hard part isn’t the idea — it’s making delivery predictable, decisions auditable, and teams able to move fast without losing control.

Through JES Consult, I work founder-adjacent across engineering, delivery, operations, product and people, helping leadership teams tighten execution, clarify roles and dependencies, and put sensible supplier and quality basics in place.

Before that, I was a founding member at Cognetivity, taking an AI-enabled SaMD from an academic concept through to an international platform. Alongside building product and engineering capability, I worked directly with quality leadership to build and certify an ISO 13485 QMS from scratch, then keep it audit-ready through six years of external audits with zero major findings — embedding ISO 14971 and IEC 62304 into day-to-day delivery. I also supported MHRA validation activity and contributed to a 15-site clinical trial resulting in CE certification.

Most recently at Closed Loop Medicine, I worked as a Senior Technical Product Manager with SaMD delivery-lead responsibilities on a UKCA-marked combination device. My focus was cross-functional alignment, practical risk and change control, and improving release/maintenance/support operations — including a roadmap pivot that removed ~£1m in cost while protecting the regulatory outcome.

ISO/IEC 42001 (PECB) — in progress. ISO 13485 — certified. BSc (Hons) Computer Science, University of Reading (masters-level dissertation; year in industry).