QARA Commercial Regional Manager

Position Summary

The QARA Commercial Regional Manager will be responsible for leading regional regulatory and quality 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, provide support on technovigilance, local labeling processes, document control; quality systems training in accordance with internal procedures. Establishes metrics, analyzes trends and reports on employee training compliance data. The incumbent is also responsible for staying abreast of evolving regulatory requirements in the region.

Principal Responsibilities

Regulatory Affairs:

• Lead and support regulatory activities to obtain and maintain product registrations and regulatory compliance across Latin America, ensuring alignment with local regulations, corporate requirements, and quality system standards.

• Monitor changes in regional regulations, assess their impact on the business, and communicate requirements and recommendations to relevant stakeholders.

• Act as the primary liaison with Regulatory Authorities, Notified Bodies, and other external agencies for product registrations, inspections, audits, and significant regulatory matters.

• Evaluate regulatory risks, resolve compliance issues, and implement mitigation and contingency plans to ensure business continuity.

• Support regulatory operations through KPI tracking, process standardization, procedural improvements, audit readiness, and cross-functional collaboration with Supply Chain, Quality, and other business functions.

• Provide guidance, training, and mentorship to team members while promoting compliance with Teleflex's Code of Conduct, company policies, and applicable regulations.

Quality Assurance:

• Ensure compliance with applicable quality standards and regulatory requirements throughout the product lifecycle, including importation, storage, distribution, commercialization, and post-market activities.

• Maintain and continuously improve the Quality Management System (QMS), including documentation, procedures, internal audits, calibration programs, quality records, and corporate reporting.

• Investigate, evaluate, and resolve quality issues, non-conformances, product complaints, field actions, ship holds, supplier quality concerns, and warehouse-related quality events, implementing appropriate corrective and preventive actions.

• Coordinate quality activities with manufacturing sites, suppliers, warehouses, regulatory authorities, and internal stakeholders to ensure product quality, regulatory compliance, and operational continuity.

• Support customer, corporate, and regulatory audits and inspections, ensuring timely preparation, execution, and follow-up of findings.

• Manage quality and regulatory databases, labeling requirements, GMP certifications, and vigilance activities while supporting importation processes and ensuring compliance with local commercialization requirements.

Education / Experience Requirements

• Fluent in English, both written and oral – essential.
• Bachelor Degree in engineering, medical, or science field.
• Knowlege in MDSAP and Brazil INMETRO requirements.
• 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.