Regulatory Affairs Executive - Devices

Dermal - Gosmore - Full Time

An opportunity has arisen for a Regulatory Affairs Executive to join the devices Regulatory team. Reporting to the Devices Regulatory Lead, we are seeking a highly motivated, clear thinking and well organised individual with excellent communication skills who is comfortable with working to tight deadlines in a fast-paced and ever-changing environment.

 

Key responsibilities include the planning, preparation and submission of technical documentation and required changes to the Notified Body. Additionally, preparation and maintenance of supporting regulatory documentation, technical reports and SOPs will be required. It is therefore essential that the successful candidate has effective verbal and written communication skills, with the ability to present complex issues in a clear, logical and persuasive way and the confidence to defend an expert opinion. Meticulous attention to detail as well as strong organisational and planning skills are essential.

 

It will be necessary to provide guidance and support to other departments, particularly Pharmaceutical Development Support (PDS), Purchasing & Supply (P&S) and Production. Therefore, over time, it will be important to develop and maintain regulatory knowledge and highlight any upcoming changes to help identify the potential impact on planned and existing products and associated practices/procedures.

 

The successful candidate will ideally have medical device regulatory experience, a degree in a relevant scientific discipline and previous experience in a pharmaceutical environment. Whilst previous regulatory affairs experience is desired, it is not essential, as consideration will be given to an individual who exhibits a keen desire to expand upon their existing experience from a pharmaceutical environment. Computer competence and experience of document management systems and/or eCTD submission are also desirable.