Regulatory Affairs Specialist EMEA

📋 Description

• Assess regulatory impact within EMEA (EU/EEA, Middle East, Africa) and support implementation of
• Provide guidance to cross-functional teams, ensuring product development and changes are in line
• Manage the preparation, submission, and maintenance of EMEA medical device registration dossiers
• Coordinate registration strategy with cross-functional partners such as Product Lifecycle
• Prepare and review regulatory correspondence, Letters of Notification, declarations, certificates
• Monitor and perform sustaining activities including renewals, amendments, and change notifications

🎯 Requirements

• Bachelor's or Master's degree in Engineering, Medical Technology, or a related field is highly
• Proficiency in English, with a minimum of C1 level proficiency in both written and spoken forms.
• 5+ years of experience in regulatory affairs within the medical device industry.
• Experience with medical device registration lifecycle management, including new registrations
• Experience with regulatory impact assessments and change notification strategies.
• Advanced understanding of Global regulatory requirements and standards for Medical Devices relevant