Education and Professional Membership

•  BSc Chemistry Degree
•  MChem Masters in Chemistry
•  PGCERT ‘Medical Device Quality Assurance and Regulatory Affairs’
•  BSI Medical Device Regulation Professional Certification
•  Member of Team PRRC, ABHI, RAPS and UKRPA

Profile

Julie is a passionate and highly motivated regulatory affairs and quality management professional with 22 years’ experience working within the medical device industry, with both in vitro medical devices and general medical devices. Julie has benefited from working with both small start-up companies and some of the largest Medical Device companies globally and therefore has experience to adapt regulatory solutions to the organizational needs.

Skilled in all phases of lifecycle management of medical devices, CE Marking, UKCA, Clinical Evaluations, Risk Management, Notified/ Approved Body and Competent Authority audits, Global Regulatory Requirements, EU MDR, ISO 13485: 2016 lead auditor and experience working with U.S. Food and Drug Administration (FDA).

Offers UKRP, EUAR, PRRC and Technical Responsible Person services as well as international regulatory support.