Regulatory Affairs manager Medical Devices A new role in Regulatory Affairs has become available at an exciting medical devices organisation who have products undergoing clinical trials. The role focuses on FDA and UK/EU submissions As an experienced Regulatory Affairs professional, you ll manage and prepare regulatory submissions (e.g., variations, renewals, new market applications) and ensure compliance with U.S. (FDA) and European (EMA) regulations. Key responsibilities include strategic planning, cross-functional coordination with manufacturing, quality assurance, regulatory writing and document review, and liaising with health authorities. The company has exciting medical device products currently undergoing clinical trials. Head office is based in Oxfordshire. Key Responsibilities Submission Strategy: Developing strategic plans for regulatory submissions, including variations, renewals, and new market applications. Document Preparation: Writing, reviewing, and ensuring the accuracy and compliance of submission documents, such as Chemistry, Manufacturing, and Controls (CMC) data, study reports, and other regulatory materials. Regulatory Compliance: Ensuring all submissions and regulatory activities meet the requirements of the FDA (U.S.) and European Medicines Agency (EMA). Cross-Functional Coordination: Collaborating with internal teams (manufacturing, quality assurance, quality control, etc.) and external partners to gather necessary information for su