Regulatory Affairs Specialist

This role is ideal for a regulatory professional with strong experience in FDA, Health Canada, and EU medical device requirements. The Regulatory Affairs Specialist will maintain global registrations and technical documentation, support audits, manage product compliance throughout the lifecycle, and provide strategic regulatory input to cross-functional teams.

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  Maintain and update European technical files, including risk assessments, usability reports, and clinical evaluations

  
  


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  Prepare and execute annual regulatory registrations for the U.S. (FDA), Canada, and other global markets

  
  


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  Assist international distributors with product registration and compliance requirements

  
  


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  Review product changes to ensure ongoing regulatory conformity

  
  


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  Evaluate product label...