Regulatory Affairs Specialist

iO Associates have partnered with a growing medical device company based in the Cotswolds. They are looking for a Regulatory Affairs Specialist to join the team. The business has had some investment recently and are going on a journey of growth and development, and with some exciting new products in the pipeline, it's a great time to be joining the company.

There's plenty of personal growth and progression opportunity too and unlike larger organisations, you will vividly see the impact you have on the business. They look after their staff with modern approach to working in the form of flexi time arrangements and also have access to LinkedIn learning with thousands of online course for you to access and continually develop yourself.

With the upcoming changes to the medical device regulations this role is crucial to the business being able to push on with their growth and NPD plans. As the RA specialist you will be responsible for creating, maintaining and managing Technical Files for UK and international markets including Europe (MDR), Canada and the USA.

You will be managing the change control system as well playing an integral part in obtaining and maintaining UKCA approval, CE certification and FDA clearance. This will involve collating technical files, maintaining DHFs and risk management files as well as creating STED files and performance requirement checklists.

Additionally you will act as the regulatory project leader for NPI, providing support for NC/CAPAs where required.

To be successful in this role you will need:

• A bachelor's degree in life sciences or engineering, or equivalent
• Minimum of four years experience in Medical Devices
• Knowledge of regulatory submissions and technical file creation/maintenance (EU and USA)
• Excellent working knowledge of Microsoft Office (outlook, word and excel)
• An understanding of Quality Management Systems is essential
• Ability to explain complex technical details in a clear and concise manner.
• Ability to review and draw conclusions from data on complex subjects eg. technical documentation, scientific literature

In return you will receive a salary of £45,000 along with benefits including company pension, flexi time, healthcare plan and much more.

If you meet most of the criteria for this role and you would like to find out more, don't hesitate to get in touch today and apply!