Your mission
The Regulatory Affairs managers provides regulatory affairs leadership across the business within a highly regulated medical devices and combination product environment. This role will be particularly responsible for:
• Implement and maintain regulatory affairs policies and procedures to ensure regulatory compliance
• Provide regulatory guidance to the development teams
• Preparation and submission of new products i.e. 510(k) or in declaring CE conformity
• Monitoring regulations, guidelines, and standards
• Implement and maintain regulatory affairs policies and procedures to ensure regulatory compliance
• Provide regulatory guidance to the development teams
• Preparation and submission of new products i.e. 510(k) or in declaring CE conformity
• Monitoring regulations, guidelines, and standards