Regulatory Affairs Specialist – Medical Devices - Global Medical Devices Company - South Yorkshire - £negotiable, 5% bonus, pension, healthcare, 25days holiday + BH

The Regulatory Affairs Specialist is responsible for submitting and maintaining global regulatory approvals for new medical device products as well as maintaining registrations and licences in existing markets.

The Company

This is an exciting time to join highly successful, well established, global orthopaedics company based at their site in South Yorkshire. They develop and manufacture their own products and have an excellent R&D capability ensuring they stay at the forefront of medical devices particularly within orthopaedics.

• Global, well established orthopaedics company 
• Their products are used in a high number of UK hospitals
• Manufacture and register a range of high-quality devices as well as many more in the pipeline
• At the forefront of medical devices on a global basis

The Role

The Regulatory Affairs Specialist will be responsible for;

• Submit and maintain global regulatory approvals, supporting regulatory submissions for new markets and maintaining registrations and licences in existing markets.
• Liaise with Notified Bodies in relation to submissions and changes to current submissions
• Ensure compliance across all devices to the relevant legislations

You

To apply for this role as a Regulatory Affairs Specialist our client is hoping for someone with the following skills and experience;

• Good regulatory experience within medical devices
• Good knowledge of MDD/MDR
• Good knowledge of ISO 134585
• Science based degree

What should you do next?

This Regulatory Affairs Specialist role is one not to be missed; it encompasses the opportunity to work in a highly successful, global orthopaedics business who are at the forefront of their market. If you are interested in this role or want to hear about any other Regulatory Affairs jobs, please get in touch.

Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.

Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.