We are currently working with a global leader within the medical device field and due to structural changes they are looking to recruit an experience Senior Director of Regulatory Affairs for their European region.
This is an essential role that will be responsible for leading a regional team and driving EU regulatory changes across the business. You will also be responsible for submission of all product submissions including Class II medical device dossiers and technical files, whilst also being responsible for the review of technical documentation and essential requirements for CE marking of products in compliance with the European regulations.
In addition to the above the role will also be responsible for our clients post market activities including but not limited to vigilance reporting and field safety actions.
This is a critical role for the business and where you will be tasked to ensure your business keeps ahead and prepared for the continued possible regulatory changes due to political and regulatory changes that may happen.
To be considered for this position candidates must have at least 10 years regulatory exposure within the medical device field, with at least 5 years senior leadership experience. It will be essential for any individual to have excellent people management skills and the communications skills to bring teams together and ensure they are all working towards the common goal.