Opportunity Description
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...
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