Principal Consultant/Managing Director - Compliance Solutions (Life Sciences) Ltd
Principal Consultant – Compliance Solutions( Life sciences) Ltd
Edwin is a Micro/Molecular Biologist with extensive experience working in the Life Sciences and Medical Devices/IVD Industry for over 20 years and has proven expertise in regulatory affairs, clinical, quality, and validation, and has recently been a member of the UK Trade and Investment Healthcare Advisory Group consulting the UK government on healthcare issues and export.
Edwin’s extensive quality, validation, and regulatory experience has encompassed roles at Smith and Nephew, Ethicon, AorTech Europe, MI Services (Consultancy), and Omega Critical Care.
Edwin also has extensive experience working with regulatory agencies e.g. Notified Bodies, MHRA, US FDA, Health Canada, and Japanese PMDA. Edwin has extensive success in regulatory strategy development and execution, including multiple US FDA 510(k) clearances and IDE and PMA approvals, as well as, CE Mark Technical File and Design Dossier approvals.
These roles involved the preparation of new and amended European (CE Marking) and US FDA Regulatory (510K, PMA, IDE, Presub’ s) submissions, development and implementation of quality systems to ISO 9001, ISO 13485, and the US FDA Quality system regulations, relocation of manufacturing processes to new manufacturing facilities and for the purposes of sub-contracting. Edwin also worked with the Scottish National Blood Transfusion Service setting up the Scottish Cord Blood Bank and a series of stem cell banks throughout the service.
Edwin is currently Principal Consultant at Compliance Solutions working with many clients including Scottish National Blood Transfusion Service, EnteroBiotix, QSpine, Current Health, Abbott, Neurovalens, Teleflex, Gyrogear, Axis Spine, Vascular Flow Technologies, Kimal, Brightwake. He has worked with all classes of devices from active to implantable, including custom devices, electronics, and software/artificial Intelligence
Edwin also currently lectures at the University of Strathclyde and Glasgow University on medical device regulations
Edwin also works with the EU Commission’s Horizon 2020 Funding Programme as a coach assisting companies with quality and regulatory advice.
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