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Regulatory Compliance Expert: (Drug/Device Combination Products) - Oxford

Regulatory Compliance Expert: (Drug/Device Combination Products) - Oxford

Up to £47,000 pa

The Company:

Our client is a Centre for Drug Delivery Devices, and is a new £10m multi-disciplinary research centre supported by a 5-year Grant in partnership with 10 industrial partners from across the medical device and pharmaceutical sectors.

The Centre will develop engineering approaches, from inception to manufacture, for device-based delivery of novel classes of anti-cancer therapeutics including siRNA, radiopharmaceuticals, viruses and antibodies.

A key focus is the exploitation of physical mechanisms triggered by ultrasound, magnetic fields or shock waves, involving a combination of stimulus-responsive nanoparticles and medical devices already in clinical use to improve the delivery and penetration of drugs into tumours.

The Role:

The successful Regulatory Compliance Expert (Drug/Device Combination Products) will work with academics and be embedded in an existing MHRA licenced facility currently manufacturing novel first in man investigational medicinal products, this new role is to be the 'devices expert'.

Responsible for ensuring that all regulatory compliance and manufacturing requirements for class III (combination) devices can be met, influencing early in the developmental lifecycle with the academics, through to manufacture and release for use in first in man clinical trials.

You will be the ?person responsible for regulatory compliance activities that possess expert knowledge in the field of medical devices''.
Working closely with the Qualified Persons who are responsible for the medicinal products, this role includes total responsibility for all regulatory aspects of the development cycle, manufacture and clinical trial use of the device parts of experimental combination devices being developed.

Due to the fast changing nature of regulations in this field this person will be the expert point of contact for academics and other staff