Regulatory Affairs Specialist

Key Responsibilities:

• Preparation and submission of regulatory dossiers (US FDA 510(k) submissions; EU CE Marking and UKCA Technical Documentation), and interface with authorities during the review process;
• Advise on strategies and registration requirements for product development and marketed products;
• Lead regulatory assessment and actions for changes to product and QMS processes.

Skills & Experience:

• 2+ years relevant experience, preferably in a Regulatory Affairs role in the life science industry.
• Hands on experience of creating documentation compliant with FDA CFR 820 and EU Medical Devices Regulation EU MDR 2017/745 required
• Experience of 510(k) submissions desirable