Angela is a Bioscientist/ Microbiologist with extensive experience of working in the Life Sciences and Medical Devices Industry for over 20 years with proven expertise in regulatory affairs, quality and validation.
Angela also has extensive experience working with regulatory agencies e.g. Notified Bodies, MHRA, US FDA, Health Canada, Japanese PMDA. Angela has extensive experience with the validation and routine processing for several modes of sterilization as well as the supporting of sterility assurance program activities covering sterilization, microbiology and sterile barrier systems.
Angela is currently Senior Consultant at Compliance Solutions working with many clients including RUA Medial, Aortech International, QSpine, Vascular Flow Technologies, Current Health, Teleflex, Sirakoss, Andersen Caledonia, Kuros Biosciences, CardioPrecsion, Brightwake, Axis Spine, Arrayjet, Flex Medical Solutions. Anglea has worked with all classes of device from active to implantable, including custom devices.
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.
Angela has driven MDR 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.