Compliance

• Supervise and develop Regulatory Commercial team members within Latin America
• Maintain release of product distribution as part of product commercialization within the region
• Ensure regulatory requirements are met per quality management systems
• Assess data from RIA and support commercial RA to ensure global market authorization needs
• Prioritize and manage projects independently based on regional objectives.
• Support tracking of Regulatory Operations Metrics from the region
• Determine and support regulatory activities which lead to and maintain regulatory compliance and approval for Teleflex Medical products in Latin America.
• Monitor regional regulations/guidelines and the impact of changing/evolving regulations on submissions, practices and procedures and communicate to appropriate stakeholders.
• Review and evaluate issues which may create regulatory or business obstacles and investigate solutions.
• Train, develop, and mentor staff as appropriate.
• Provide input to Supply and Demand Planners as needed.
• Ensure business risks have appropriate mitigation and contingency plans are in place.
• Support Regulatory procedureal consolidation while maintaining QS compliance.
• Participate in regulatory agency inspections and audits, as needed.
• Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures and housekeeping standards.

Regulatory Affairs Regional Manager

Senior Regulatory Affairs Specialist