Principal Consultant at Compliance Solutions (Life Sciences) Ltd
Senior Consultant – Compliance Solutions( Life Sciences) Ltd
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 and US FDA and has encompassed roles at Smiths Medical, Stanmore Implants and Owlstone Medical. He has worked with all classes of devices 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 the creation of quality system requirement checklists, implementation plans, supporting templates and file structures.
Working with Life Science Access Academy, our company love the variety of the many courses that are on offer. The hour long courses on specific subjects are really useful on Friday lunchtimes for our field teams and gain a lot of interest.
Life Science Access Academy are also super flexible and helpful when it comes to tailoring some additional sessions to our needs.
Frontier Medical has fully implemented, Life Science Access Academy allowing Sales and Marketing to utilise the system. Maximising on line learning for all remote staff stimulates a culture of self-development giving individuals the accountability and responsibility to broaden their skills set.
Life Science Access Academy training is topical and a good fit for the faced paced healthcare market.
I have found the training via the Life Science Access Academy to be excellent and I know many of my colleagues have as well.
The content is always kept up to date and there is huge and interesting variety of topics covered. The site is curated in a way that makes it clear and easy to navigate. Also, the staff at Life Science access Academy are friendly and responsive and all the experts are always knowledgeable in their areas.
The variety and relevancy of content brings value to many different roles across the healthcare industry.
I have also been overwhelmed by the way the Life Science Access Academy team have accommodated our own business needs, being sensitive yet responsive to helping us since its formation.