Regulatory Affairs Specialist Manager

• Act as the regulatory representative in cross-functional product development teams
  


• Ensure compliance of product documentation, including requirements, verification and validation activities, labeling, and instructions for use
  


• Develop and implement regulatory strategies for global product registration
  


• Prepare and maintain technical documentation for CE marking and ensure compliance with EU MDR (2017/745)
  


• Support regulatory submissions and approvals in the US (FDA) and Canada
  


• Monitor and ensure compliance with applicable international regulations and standards
  


• Provide regulatory guidance and interpretation to internal stakeholders
  


• Support audits and interact with regulatory authorities and notified bodies
  


• Assess product changes and ensure ongoing regulatory compliance throughout the product life cycle

CLT regime - (R$)