Jon is a Mechanical Engineer and has worked in the Medical Devices and In Vitro Diagnostics Industry for over 25 years and has proven expertise in regulatory affairs, quality and validation.
Jon also has extensive experience working with regulatory agencies e.g. MHRA, Health Canada Notified Bodies, US FDA and has encompassed roles at Smiths Medical, Stanmore Implants, Owlstone Medical. He has worked with all classes of device from active to implantable, including custom devices.
Jon is currently Senior Consultant at Compliance Solutions working with many clients including Brightwake, RD Biomed, GyroGear, Griffiths & Nielsen, Neogen, Cambridge Respiratory Innovations, Kimal, Asymptote and Surgical Innovations.
These roles involved the preparation of new and amended European (CE Marking) and US FDA Regulatory (510K) submissions, development and implementation and maintenance of quality systems to ISO 9001, ISO 13485 and the US FDA Quality system regulation. Carrying out supplier audits for companies and supporting them during certification and notified body audits.
Jon has driven MDR and IVDR gap assessments for clients to ensure a smooth transition to the regulations with implementation strategies being deployed for both Regulations along with creation of quality system requirement checklists, implementation plans, supporting templates and file structures.