Jillian Stewart

Jillian has more than 15 years’ experience in regulatory affairs and quality, including more than 10 years working with a leading global generic pharmaceutical company. She has gained expert knowledge in both medical devices and pharmaceuticals – specialising in the Irish and Maltese markets in particular – and now operates as the Principal Consultant of Jillian Stewart Regulatory Solutions.

  • The need for robust quality management

    The need for robust quality management


    It is a simple fact that the establishment of a robust quality management system (QMS) can both drive – as well as facilitate – regulatory compliance across all layers of business and operations in the pharma and MedTech industries. However, there is no doubt that the mention of QMS can ...

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    Great expectations for medical technologies


    Few would dispute that the medical technology regulatory system continues to creak under the strain imposed by the regulations on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic devices (Regulation (EU) 2017/746). At the time of going to print, the Medical Device Coordination Group (MDCG) issued proposed ...

  • brexit

    The UK and Brexit – innovation and optimism in uncertain times


    Although there is still alignment with the EU, the regulatory strategy for new submissions and variations has changed and we must adapt to such changes. No doubt further changes are on the way, which we must be ready for again.