Regulatory Affairs Executive

Educational Requirement:

M. Pharma, Medical Device / Bachelors degree with relevant experience

Experience & Skills:

• 2-3 Years of experience in Medical Devices, preferably active devices
• Strong communication and drafting skills
• Familiarity with EUMDR 2017/745 (CE Marking) & FDA 510 (K) Process

Key Responsibility:

• Identify Product Registration Requirements and preparing Dossiers for submission
• DMF preparation and compilation
• Risk Management
• Labelling Requirements for Active devices