Qualification Required:

• Bachelors/Master’s degree in Mechanical Engineering

Roles And Responsibilities

• 5 years of Regulatory experience in Medical devices
• EU MDR experience
• EUDAMED Experience
• Prior Regulatory submissions experience / International submissions (preference) or CE mark Post Approval experience
• Project Management in Regulatory will be an added advantage

Required Technical And Professional Expertise:

• EU MDR, Regulatory, EUDAMED, medical device