This role involves leading the regulatory strategy for a cardiology medical device company, focusing on FDA, CE, and UKCA submissions, and ensuring compliance with international regulations. You will work closely with the senior team and regulatory bodies, driving the company's expansion into new markets.
Develops a stabilisation fluid added to cerebrospinal fluid samples to preserve leukaemia cells for flow cytometry analysis, optimising the formulation and validating it with patient samples. The role also involves contributing to research publications and proposals and helping manage the project within a university research group.
Design and develop compact, low-power wearable medical devices from concept to production, covering system architecture, schematic and multi-layer PCB design, analog and mixed-signal circuits, and sensor/optical signal conditioning. Work on ultra-low-power battery systems and wireless interfaces (Wi-Fi, BLE, LTE-M/NB-IoT, GNSS) within a small health-tech startup, with scope to lead a hardware team.
Senior leadership role overseeing operations across biologics, RNA and medicines manufacturing facilities at two sites. Leads multidisciplinary teams covering operations, engineering, facilities and site services, ensuring GMP, health & safety and quality compliance while driving continuous improvement, capital projects and operational strategy.
