Take on a key role in regulatory affairs focusing on medical devices at an exciting organization in Oxfordshire. Manage FDA and EU regulatory submissions while ensuring strict compliance.
As a Regulatory Affairs Manager, you will handle applications, variations, and renewals, ensuring compliance with FDA and EMA regulations. Collaborate closely with manufacturing, quality assurance, and cross-functional teams, using your expertise to write and review essential documentation. Your communication with health authorities will be crucial for navigating the submission landscape.
Key Responsibilities:
• Develop regulatory submission strategies for new markets
• Review and prepare compliance documentation
• Ensure adherence to FDA and EMA standards
• Coordinate with various departments for submission data
• Interact with health authorities on regulatory affairs
Requirements:
• Strong understanding of FDA and EU regulatory frameworks
• Experience with regulatory do...