Caroline is an expert in the European medical device directives, national implementation of these within the EU Member States, labelling, vigilance, clinical trial authorizations, and device regulations in other areas of the world. She also focusses on the EU Medical Devices and IVD Regulations, expected to come into force in 2017, supporting manufacturers to ensure smooth and efficient transition.
Caroline provides clients strategic and regulatory support throughout the product development and regulatory approval processes for a wide variety of devices, identifying and reviewing both pre-clinical and clinical studies and preparing technical documentation to support CE Marking and other regulatory submissions. Caroline has spent long periods working on customer site supporting customers in vigilance (often in the context of FDA remediation) and global regulatory submissions.
Prior to joining Quintiles in 1989, Caroline worked in the European regulatory affairs department of Pfizer’s hospital products group, assisting the group’s manufacturing companies to ensure compliance of their medical devices with national European regulations. The group’s devices included non-active implantables; orthopaedics; single-use sterile devices.