We are currently working with a leading medical device manufacturing of software driven electro-machinal devices who, due to progression is seeking to recruit an experience regulatory professional for one of their fast growing and strategically important divisions within the business. This is a leadership position that will require a mix of strategic and operational kills to ensure that business stays ahead of all the International requirement, reduces time to market and is globally compliant.
You are responsible for
The role will be responsible for leading a local team for EU MDD/MDR including International Regulatory Affairs, Labelling and data management functions. You will also be responsible for the planning and overing the execution of Global regulatory submissions for new and existing product lines. Plus working closing as the organisation’s key subject matter expert for colleagues in R&D, Quality, Marketing, and Clinical on all aspect of product life cycle for global compliance.
To be successful you will need to demonstrate a minimum of 5 years Regulatory submissions experience along with a minimum of 2 years of leaderships. Due to the global nature of this role, you will need a successful track record of global medical device regulations including technical file creation plus an understanding of software driven electromechanical products.
This is an excellent opportunity to join a global organisation and have a critical impact on the success of the business.