Asc Regulatory Affairs Specialist (3-year contract)

Position Summary

In regulatory we are responsible for ensuring that vascular intervention medical devices are developed, manufactured, and distributed in strict compliance with global healthcare laws registrations and for submission and approval in highly regulated countries including Europe, US and Canada. 

Principal Responsibilities

• 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 registration of medical devices and regulatory assessment of changes in Europe and other highly regulated countries
• Literate in Microsoft Office and Adobe Acrobat applications
• Reliable and communicative personality 
• Ability to work in multidisciplinary teams with different backgrounds (R&D, Production, Quality, Marketing, Clinical)
• Attention to details, excellent organization and analytical skills, and ability to work simultaneously on multiple and sometimes urgent projects with tight timelines.
• Ability to adapt to program/timeline changes as needed
• Fluency in English is mandatory