Asc Regulatory Affairs Specialist (3-year contract)

Position Summary

• Assessment of design and manufacturing changes to ensure compliance with regulatory requirements and that sufficient information is available to perform the regulatory impact assessment of the change
• Coordinate and contribute to worldwide assessment of changes and support the related product and production lifecycle activities
• Maintain regulatory documentation up to date for worldwide regulatory purposes
• Support the registration of changes for class II and III devices in the CE, US, Japan and other highly regulated countries
• Coordinate and submit deficiency responses to relevant certification bodies and country authorities

Education / Experience Requirements

• University degree in natural science, pharmacy, pharmacology, medicine or engineering
• At least 2 years of experience with the registra...