Regulatory Affairs Specialist managing product regulatory compliance and submission processes. Collaborating with teams to ensure adherence to regulatory requirements and supporting product approvals.
Responsibilities
Support regulatory compliance for marketed products
Prepare U.S. and international submission content
Work with cross-functional teams for regulatory support
Maintain awareness of worldwide regulatory requirements
Requirements
Bachelor's degree
2+ years of regulatory experience
Knowledge of FDA Class II or III devices
Experience with EU Class IIb or III devices
Ability to manage and prioritize multiple projects
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