Regulatory Affairs Specialist

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

• 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.