Regulatory Affairs Commercial Regional Manager

Position Summary

The Regulatory Affairs Commercial Regional Manager will be responsible for leading regional regulatory staff for regulated markets in LATAM such as product registrations, including preparing regulatory strategies, managing submissions and interaction with third parties and/or various regulatory agencies. The incumbent is also responsible for staying abreast of evolving regulatory requirements in the region.

Principal Responsibilities

• 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.

Education / Experience Requirements

• Fluent in English, both written and oral – essential
• Bachelor Degree in engineering, medical, or science field.
• 7+ years experience in Regulatory Affairs for different LATAM regulations in Medical Devices.
• 3+ years exprience in Regulatory Affairs leadership roles for Medical Devices.

Specialized Skills / Other Requirements

• Highly organized with strong attention to detail and ability to prioritize multiple tasks.
• Self-starter who takes initiative and follows through on written and verbal instructions.
• Excellent written and verbal communication skills with strong cross-functional collaboration.
• Skilled in proofreading technical documentation for accuracy and consistency.
• Demonstrated problem-solving ability; adaptable to shifting priorities and changing project needs.
• Proficient in Microsoft Office (Excel, Word, PowerPoint) and statistical or analytical software.
• Knowledge of Corrective Action, Manufacturing, and Design Control concepts preferred.
• Positive, proactive, and effective in working across teams and with leadership.