Senior Regulatory Affairs Specialist
This role involves managing regulatory compliance for advanced wound care medical devices throughout their lifecycle, including preparing global regulatory submissions, guiding product development teams, and liaising with regulatory authorities. The specialist ensures adherence to standards such as ISO 13485, FDA 21 CFR Part 820, cGMP, and cGDP, while reviewing product documentation and supporting continuous improvement. Based in Hull, the position operates within a collaborative, global team environment focused on bringing innovative healthcare products to market.