Tara is a Biologist with extensive experience of working in the Medical Devices and In Vitro Diagnostics Industry for over 10 years and has proven expertise in regulatory affairs, quality. Tara is an experienced clinical project manager and trained clinical monitor, allowing her to successfully drive clinical strategies for clients, liaising and submitting to competent authorities and hosting regulators for multi-site clinical trials, as well as communication dialogues with ethics committees and all aspects of reporting requirements to ensure smooth regulatory clearance post-trial at the point of the submission process.
Tara also has extensive experience working with regulatory agencies e.g. MHRA, Notified Bodies, US FDA.
Tara is currently Senior Consultant at Compliance Solutions working with many clients including Qiagen, NeuroValens, Abbott, Apis Assay and Surgical Innovations.
These roles Tara has been involved the preparation of new and amended European (CE Marking) and US FDA Regulatory (510K, IDE, Presub’ s) submissions, development and implementation of quality systems to ISO 9001, ISO 13485 and the US FDA Quality system regulations.
Tara has driven MDR and IVDR gap assessments for multi-national 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.